Cumulative list of all products that have received Orphan Designation

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Cumulative List of Designated Approved Orphan Products Total Number of Active Designations 1841 Generic Name: Designation Approved: Effective: 4/15/2008 Trade Name (if present): Theralux photodynamic therapy Date Designated 4/3/2008 Date Approved Sponsor Contact Information Kiadis Pharma Canada, Inc. 2525 Marie Curie Montreal (Quebec) H4S 2E1 CANADA Generic Name: Designation Approved: Trade Name (if present): AGT-181 Date Designated 1/10/2008 Date Approved Sponsor Contact Information ArmaGen Technologies, Inc. 914 Colorado Ave. Santa Monica CA 90401 Generic Name: Designation Approved: Trade Name (if present): Valortim Date Designated 2/16/2006 Date Approved Sponsor Contact Information PharmAthene, Inc. One Park Place Suite 450 Annapolis MD 21401 Generic Name: (+/- cis-3-(4-hydroxyphenyl)-4-(4methoxphenyl)-3,4-dihydro-2H-chromen-7-01 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/10/2008 Date Approved Marshall Edwards, Inc. 140 Wicks Road AUSTRALIA Generic Name: (+/-)-7-[3-(4-acetyl-3-methoxy-2propylphenoxy)propoxy]-3,4-dihydro-8propyl-2H-1-benzopyran-2-carboxylic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/31/2003 Date Approved Intarcia Therapeutics, Inc. 2000 Powell Street Suite 1640 Emeryville CA 94608 Generic Name: (+/-)-cis-3-(4-hydroxyphenyl)-4-(4methoxyphenyl)-3,4-dihydro-2H-chromen-7Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/10/2008 Date Approved Marshal Edwards, Inc. 140 Wicks Road AUSTRALIA Generic Name: (+/-)-cis-3-(4-hydroxyphenyl)-4-(4methoxyphenyl)-3,4-dihydro-2Hchromen-7Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/2008 Date Approved Marshall Edwards, Inc. 140 Wicks Road AUSTRALIA Generic Name: (1R,2S) 6-bromo-alpha-[2(dimethylamino)ethyl]-2-methoxy-alpha-(1naphthyl)-beta-phenyl-3-quinolineethanol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/10/2005 Date Approved Tibotec, Inc. 1020 Stony Hill Road Yardley PA 19067 Generic Name: (1S)-1-(9-deazahypoxanthin-9-yl)-1,4dideoxy-1,4-imino-D-ribitol-hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/10/2004 Date Approved BioCryst Pharmaceuticals, Inc. 2190 Parkway Lake Drive Birmingham AL 35244 Generic Name: (1S)-1-(9-deazahypoxanthin-9-yl)-1,4dideoxy-1,4-imino-D-ribitol-hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/13/2004 Date Approved BioCryst Pharmaceuticals, Inc. 2190 Parkway Lake Drive Birmingham AL 35244 Generic Name: (1S)-1-(9-deazahypoxanthin-9-yl)-1,4dideoxy-1,4-imino-D-ribitol-hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/29/2004 Date Approved BioCryst Pharmaceuticals, Inc. 2190 Parkway Lake Drive Birmingham AL 35244 Generic Name: (2Z)-2-cyano-3-3hydroxy-N-[4(trifluoromethly)phenyl]-2-hepten-6-ynamide Trade Name (if present): FK778 Date Designated 1/10/2005 Date Approved Designation Approved: Sponsor Contact Information Fujisawa Healthcare, Inc. Three Parkway North Deerfield IL 60015-2548 Generic Name: (3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3yl]-benzoic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/1/2004 Date Approved PTC Therapeutics 100 Corporate Court South Plainfield NJ 07080 Generic Name: (3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3yl]-benzoic acid) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/10/2005 Date Approved PTC Therapeutics, Inc. 100 Corporate Court South Plainfield NJ 07080 Generic Name: (3-[5-(2fluorophenyl)-1,2,4-oxadiazol-3-yl]benzoic acid) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/10/2008 Date Approved PTC Therapeutics, Inc. 100 Corporate Court South Plainfield NJ 07080 Generic Name: (3S)-3-(4-trifluoromethoxybenzyloxy)-6nitro-2H-3,4-dihydroimidazo[2,1-b]oxazine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/5/2007 Date Approved Global Alliance for TB Drug Development 80 Broad Street New York NY 10004 Generic Name: (3S)-3-[(2S)-2-({N-[2-tertbutyl)phenyl]carbamoyl}carbonylamino) propanoylamino]-4-oxo-5-(2,3,5,6tetrafluorophenoxy) pentanoci acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/19/2003 Date Approved Pfizer Global Research and Development 50 Pequot Avenue New London CT 06320 Generic Name: (4S)-4-ethyl-4-hydroxy-3,14-dioxo-3,4,12,14tetrahydro-1-H-pyrano[3?,4?:6,7]-indolizino[1,2-b]-quinoline-11-carbaldehyde O-(tertbutyl)-(E)-oxime Trade Name (if present): Gimatecan Date Designated 11/29/2002 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaceuticals Corporation One Health Plaza Building 105 East Hanover NJ 07936-1080 Generic Name: (6R,S)5,10-methylene-tetrahydrofolic acid Trade Name (if present): CoFactor Date Designated 8/13/2004 Date Approved Designation Approved: Sponsor Contact Information Adventrx Pharmaceuticals, Inc. 6725 Mesa Ridge Road Suite 100 San Diego CA 92121 Generic Name: (9-[N-(3-morpholinopropyl)-sulfonyl]-5,6dihydro-5-oxo-11-H-indeno [1,2-c] isoquinoline methanesulfonic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/8/2004 Date Approved Inotek Pharmaceuticals Corporation 100 Cummings Center Beverly MA 01915 Generic Name: (R)-2-methyl-6-nitro-2-{4-[4-(4trifluoromethoxyphenoxy)piperidin-1yl]phenoxymethyl}-2,3-dihydroimidazo[2,1b]oxazole Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/12/2007 Date Approved Otsuka Pharmaceutical Company, Ltd 2440 Research Blvd Rockville MD 20850 Generic Name: (R)-4-(3-morpholin-4-yl-1phenylsulfanylmethyl-propylamino)-N-(4-{4[2-(4-chlorophenyl)-5,5-dimethylcyclohex-1enylmethyl]-piperazin-1-yl}-benzoyl)-3trifluoromethanesulfonylbenzenesulfonam ide bis-hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/19/2007 Date Approved Abbott Laboratories 200 Abbott Park Road AP34/RA72 Abbott Park IL 60064-6188 Generic Name: (R)-4-(3-morpholin-4-yl-lphenylsulfanylmenthyl-propylamino)-N-(4{4-[2-(4-chlorophenyl)-5,5dimethylcyclohex-l-enylmethyl]-piperazin-lyl}-benzoyl)-3trifluoromethanesulfonylbenzenesulfonam ide bis-hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/19/2007 Date Approved Abbott Laboratories 200 Abbaott Park Road AP34/RA72 Abbott Park IL 60064-6188 Generic Name: (R)-N-[2-(6-chloro-5-methoxy-1H-indol-3yl)propyl]acetamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/3/2001 Date Approved Phase 2 Discovery, Inc. 3130 Highland Avenue, Third Floor Cincinnati OH 45219-2374 Generic Name: (R)-N-[2-(6-Chloro-methoxy-1H-indol3yl)propyl]acetamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/3/2003 Date Approved Phase 2 Discovery, Inc. 3130 Highland Ave. Third Floor Cincinnati OH 45219 Generic Name: (UDU-stereoisomer of c-UJUun UNUterminal UkUnhibitor) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/28/2006 Date Approved Auris Medical, Inc. 211 East Ontario Street Chicago IL 60611 Generic Name: [5,10,15,20-tetrakis(1,3-diethylimidazolium2-yl)porphyrinato] Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/4/2003 Date Approved Aeolus Pharmaceuticals, Inc. PO Box 14287; 79 T.W. Alexander Dr. 4401 Research Research Triangle Park NC 27709 Generic Name: 1,1'-[1,4-phenylenebis(methylene)-bis1,4,8,11-tetraazacyclotetradecan Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/10/2003 Date Approved Genzyme Corporation 500 Kendall Street Cambridge MA 02142 Generic Name: 1,2-bis(methylsulfonyl)-1-(2-chloroethyl)-2[(methylamino)carbonyl]hydrazine Trade Name (if present): Cloretazine Date Designated 10/21/2004 Date Approved Designation Approved: Sponsor Contact Information Vion Pharmaceuticals, Inc. Four Science Park New Haven CT 06511 Generic Name: 1,5-(Butylimino)-1,5 dideoxy,D-glucitol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/12/1998 Date Approved Oxford GlycoSciences 10, The Quadrant Abington Science Park United Kingdom UNITED KINGDOM Generic Name: 11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa5,7,26-triazatetracyclo[19.3.1.12,6.18,12}heptacosa1(25),2(26),3,5,8,10,12(27),16,21,23-decaene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/13/2008 Date Approved S*BIO Pte., Ltd. 1 Science Park Road Singapore Science Park II SINGAPORE Generic Name: 111Indium pentetreotide Trade Name (if present): SomatoTher Date Designated 6/10/1999 Date Approved Designation Approved: Sponsor Contact Information Louisiana State University Medical Center Foundation 1600 Canal St. 10th Floor New Orleans LA 70112 Generic Name: 166Ho-DOTMP Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/10/1999 Date Approved NeoRx Corporation 410 W. Harrison Street Seattle WA 98119-4007 Generic Name: 17 a-Hydroxyprogesterone caproate Trade Name (if present): Gestiva Date Designated 1/25/2007 Date Approved Designation Approved: Sponsor Contact Information Cytyc Corporation 1240 Elko Drive Sunnyvale CA 94089 Generic Name: 17-allylamino-17-demethoxygeldanamycin (17-AGG) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/3/2004 Date Approved Kosan Biosciences, Inc. 3832 Bay Center Place Hayward CA 94545 Generic Name: 1-Deoxygalactonojirimycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/25/2004 Date Approved Amicus Therapeutics, Inc. 6 Cedar Brook Drive Cranbury NJ 08512 Generic Name: 1-dexynojirimycin hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/18/2007 Date Approved Amicus Therapeutics, Inc 6 Cedar Brook Drive Cranbury NJ 08512 Generic Name: 2-(3,5-dichloro-phenyl)-benzoxazole-6carboxylic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/23/2006 Date Approved FoldRx Pharmaceuticals, Inc. 300 Technology Square Cambridge MA 02139 Generic Name: 2-(3-diethylaminopropyl)-8,8-dipropyl-2azaspiro [4,5] decan dimaleate Trade Name (if present): Atiprimod Date Designated 12/2/2003 Date Approved Designation Approved: Sponsor Contact Information Callisto Pharmaceuticals, Inc. 2 Executive Drive Suite 450 Somerset NJ 08873 Generic Name: 2-(3-Diethylaminopropyl)-8,8-dipropyl-2azaspiro[4,5] decane dimaleate Trade Name (if present): Atiprimod Date Designated 9/18/2006 Date Approved Designation Approved: Sponsor Contact Information Callisto Pharmaceuticals, Inc. 420 Lexington Avenue New York NY 10170 Generic Name: 2',3',5'-tri-o-acetyluridine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/13/2003 Date Approved Repligen Corporation 41 Seyon Street Building 1, Suite 100 Waltham MA 02453 Generic Name: 2,6-Benzothiazolediamine, 4,5,6,7tetrahydro-N6-propyl-, dihydrochloride, monohydrate, (6R)-; (6R)-4,5,6,7-tetrahydroN6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/2007 Date Approved Knopp Neurosciences, Inc. 2100 Wharton Street Pittsburgh PA 15203 Generic Name: 2-[(R)-2-methylpyrrolidin-2-yl]-1Hbenzimadazole-4-carboxamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2007 Date Approved Abbott Laboratories Global Pharmaceutical Research and Development 200 Abbott Park Road Abbott Park IL 60064-6157 Generic Name: 2-0-Butyryl-1-0-octyl-myo-inositol 3,4,5,6tetrakisphosphate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/15/2003 Date Approved Inologic, Inc. 101 Elliott Ave., West Seattle WA 98119 Generic Name: 2-0-desulfated heparin Trade Name (if present): Aeropin Date Designated 9/17/1993 Date Approved Designation Approved: Sponsor Contact Information Kennedy & Hoidal, M.D.'s University of Utah Health Sciences Center 50 North Medical Drive, Room 4R240 Salt Lake City UT 84132 Generic Name: 20-mer complementary to Akt mRNA Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/10/2004 Date Approved Rexahn Corporation 9620 Medical center Drive Rockville MD 20850 Generic Name: 20-mer oligonucleotide complementary to Akt mRNA Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/8/2004 Date Approved Rexahn Corporation 9620 Medical Center Drive Rockville MD 20850 Generic Name: 20-mer oligonucleotide complementary to Akt mRNA Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/8/2004 Date Approved Rexahn Corporation 9620 Medical center Drive Rockville MD 20850 Generic Name: 20-mer oligonucleotide complementary to Akt mRNA Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/1/2004 Date Approved Rexahn Corporation 9620 Medical Center Drive Rockville MD 20850 Generic Name: 20-mer oligonucleotide complementary to Akt mRNA Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/1/2004 Date Approved Rexahn Corporation 9620 Medical Center Drive Rockville MD 20850 Generic Name: 2'-3'-dideoxyadenosine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/21/1987 Date Approved National Cancer Institute, Dct NIH, Exec. Plaza N., Room 7-18 Bethesda MD 20892 Generic Name: 24,25 dihydroxycholecalciferol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/27/1987 Date Approved Lemmon Company 1510 Delp Drive Kulpsville PA 19443 Generic Name: 2-chloroethyl-3-sarcosinamide-1nitrosourea Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/2001 Date Approved Lawrence Panasci, MD Professor of Medicine, McGill University 3755 Cote Ste Catherine Montreal, Quebec H3T 1E2 CANADA Generic Name: 2-chloroethyl-3-sarcosinamide-1nitrosourea Trade Name (if present): Sarmustine Date Designated 11/15/2001 Date Approved Designation Approved: Sponsor Contact Information Pangene Corporation 5500 Stewart Avenue Fremont CA 94538 Generic Name: 2'-deoxycytidine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/9/1996 Date Approved Grant, Steven M.D. Massey Cancer Center, VCU P.O. Box 980230 Richmond VA 23298-0230 Generic Name: 2-methoxyestradiol Trade Name (if present): PulmoLAR Date Designated 4/11/2005 Date Approved Designation Approved: Sponsor Contact Information PR Pharmaceuticals, Inc. 1716 Heath Parkway Fort Collins CO 80524 Generic Name: 2-methoxyestradiol Trade Name (if present): Panzem NCD Date Designated 4/4/2005 Date Approved Designation Approved: Sponsor Contact Information EntreMed, Inc. 9640 Medical Center Drive Rockville MD 20850 Generic Name: 2-methoxyestradiol Trade Name (if present): Panzem Date Designated 6/16/2006 Date Approved Designation Approved: Sponsor Contact Information EntreMed, Inc. 9640 Medical Center Drive Rockville MD 20850 Generic Name: 2-methoxyestradiol Trade Name (if present): Panzem Date Designated 7/10/2001 Date Approved Designation Approved: Sponsor Contact Information EntreMed, Inc. 9640 Medical Center Drive Rockville MD 20850 Generic Name: 2'-O-methyl-phosphorothiolate oliogribonucleotide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/18/2005 Date Approved Prosena B.V. Einsteinweg 55 NETHERLANDS Generic Name: 3-(3,5-Dimethyl-1H-2ylmethylene)-1,3dihydro-indol-2-one Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/23/2000 Date Approved Sugen, Inc. 230 East Grand Ave. South San Francisco CA 94080 Generic Name: 3-(3,5-dimethyl-1H-2ylmethylene)-1,3dihydro-indol-2-one Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/11/1998 Date Approved Sugen, Inc. 230 East Grand Ave. South San Francisco CA 94080-4811 Generic Name: 3,4-diaminopyridine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/1990 Date Approved Jacobus Pharmaceutical Company 37 Cleveland Avenue P.O. Box 5290 Princeton NJ 08540 Generic Name: 3,5,3'-triiodothyroacetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/20/2000 Date Approved Elliot Danforth, Jr., M.D. University of Vermont 84 Beartown Road Underhill VT 05489 Generic Name: 3'-azido-2',3'dideoxyuridine Trade Name (if present): AZDU Date Designated 11/20/1989 Date Approved Designation Approved: Sponsor Contact Information Berlex Laboratories, Inc. 1401 Harbor Bay Parkway Alameda CA 94501 Generic Name: 4-(2-fluorophenyl)-6-methyl-2-(1-piperzinyl) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/2006 Date Approved Dynogen Pharmaceuticals, Inc. 52 Second Avenue Waltham MA 02451 Generic Name: 4-(3-Methanesulfonyl-phenyl)-1propylpiperidine HCl Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/12/2005 Date Approved A. Carlsson Research AB Joakim Tedroff, M.D. S-412 46 Goteborg SWEDEN Generic Name: 4,5 dibromorhodamine methyl ester Trade Name (if present): Theralux Photodynamic Therapy Date Designated 10/23/2007 Date Approved Designation Approved: Sponsor Contact Information Kiadis Pharma Canada, Inc. 2525 Marie Curie Canada H4S 2E1 CANADA Generic Name: 4,5-dibromorhodamine 123 Trade Name (if present): Theralux Irradiation Device Date Designated 4/10/2003 Date Approved Designation Approved: Sponsor Contact Information Kiadis Pharma Canada, Inc. 2525 Marie-Curie Saint-Laurent (Quebec) H4S 2E1 CANADA Generic Name: 40SD02 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/21/1998 Date Approved Biomedical Frontiers, Inc. 1095 10th Ave., S.E. Minneapolis MN 55414 Generic Name: 4-Amino-1-[5-O-[(2R, 4S)-2-oxido-4-(4pyridinyl)-1, 3, 2-dioxaphosphorinan-2-yl]-bD-arabinofuranosyl]-2(1H)-pyrimidinone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/22/2007 Date Approved Metabasis Therapeutics, Incorporated 11119 North Torrey Pines Road LaJolla CA 92037 Generic Name: 4-Aminopyridine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/14/2005 Date Approved Acorda Therapeutics, Inc. 15 Skyline Drive Hawthorne NY 10532 Generic Name: 4-aminosalicylic acid Trade Name (if present): Paser Granules Date Designated 4/26/2006 Date Approved Designation Approved: Sponsor Contact Information Jacobus Pharmaceutical Co., Inc. 37 Cleveland Lane Princeton NJ 08540 Generic Name: 4-aminosalicylic acid Trade Name (if present): Pamisyl (P-D), Rezipas (Squibb) Date Designated 12/13/1989 Date Approved Designation Approved: Sponsor Contact Information Beeken, Warren M.D. University Of Vermont Given C-317 Burlington VT 05405 Generic Name: 4-cholest-en-3-one, oxime Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/1/2005 Date Approved Trophos SA Parc scientifique de Lumigny, Case 931 1322 Marseille cedex FRANCE Generic Name: 4-cyano-N-[2-(1-cyclohexen-1-yl)-4-[1[dimethylamino)acetyl]-4piperidinyl]phenyl]-1H-imidazole-2carboxamide monohydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/20/2006 Date Approved Johnson & Johnson Pharmaceutical Research & Dev, 920 U S Highway 202 P.O. Box 300 Raritan NJ 08869 Generic Name: 4-trifluoromethyl-N-(3.3a.4.4a.5,5a,6,6aoctahydro-1,3-dioxo4,6ethenocycloprop[f]isoindol-2(1H)-yl)benzamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/27/2006 Date Approved SIGA Technologies, Inc. 4575 SW Research Way Corvallis OR 97333 Generic Name: 4-trifluoromethyl-N-(3.3a.4.4a.5,5a,6,6aoctahydro-1,3-dioxo4,6ethenocycloprop[f]isoindol-2(1H)-yl)benzamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2006 Date Approved SIGA Technologies, Inc. 4575 SW Research Way Corvallis OR 97333 Generic Name: 5(S)-(2'-hydroxy ethoxy)-20(S)Camptothecin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/15/2007 Date Approved ClinTec International Ltd. 1055 Westlakes Drive Berwyn PA 19312 Generic Name: 5,12-Naphthacenedione, 10-[[3-amino-2,3,6trideoxy-4-O-(phenylmethyl)-a-L-lyxohexopyranosyl]oxy]-7,8,9,10-tetrahydro6,8,11-trihydroxy-8-(hydroxyacetyl)-1methoxy-, hydrochloride, (8S,10S)- (9CI) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/2006 Date Approved Reata Pharmaceuticals, Inc. 1950 N. Stemmons Freeway Dallas TX 75207-3199 Generic Name: 5,5',5"-[Phosphinothioylidyne-tris(imino2,1-ethanediyl)]tris[5methylchelidoninium]trihydroide hexahydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/20/2003 Date Approved Now Pharm AG 241, route d'Arlon L-1150 LUXEMBOURG Generic Name: 5,6-dihydro-5-azacytidine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/11/1992 Date Approved ILEX Oncology, Inc. 4545 Horizon Hill Blvd. San Antonio TX 78229-2263 Generic Name: 5,7-dihydroxy-3-(4-hydroxyphenyl)chromen-4-one Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/18/2007 Date Approved Humanetics, Inc. 10400 Viking Drive Eden Prairie MN 55344 Generic Name: 5-[(E)-2-(4-hydroxyphenyl)-ethenyl] benzene-1,3 diol Trade Name (if present): Resveratrol Date Designated 3/13/2008 Date Approved Designation Approved: Sponsor Contact Information Sirtris Pharmaceuticals, Inc. 200 Technology Square Cambridge MA 02139 Generic Name: 506U78 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/2/1999 Date Approved GlaxoSmithKline Five Moore Dr. P.O. Box 13398 Research Triangle Park NC 27709-3398 Generic Name: 5a8, monoclonal antibody to CD4 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/20/1993 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: 5-aza-2'-deoxycytidine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/1987 Date Approved SuperGen, Inc. 4140 Dublin Blvd. Suite 200 Dublin CA 94568 Generic Name: 5-hydroxymethyl-2-furfuraldehyde Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/26/2006 Date Approved Xechem International, Inc. New Brunswick Technoloogy Center Building 1, Suite 310 New Brunswick NJ 08901-3279 Generic Name: 5-iodo-2-pytimidinone-2'-deoxyribose Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/26/2006 Date Approved Hana Biosciences, Inc. 7000 Shoreline Court Suite 370 South San Francisco CA 94080 Generic Name: 5-methyl-1-phenyl-2-(1H)-pyridone(CAS 53179-13-8) Trade Name (if present): Pirfenidone Date Designated 3/5/2004 Date Approved Designation Approved: Sponsor Contact Information InterMune, Inc. 3280 Bayshore Blvd Brisbane CA 94005 Generic Name: 6 alpha-ethylchenodeoxycholic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/9/2008 Date Approved Intercept Pharmaceuticals, Inc. 18 Desbrosses Street New York NY 10013 Generic Name: 6,8-bis-benzylsulfanyl-octanoic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/6/2006 Date Approved Cornerstone Pharmaceuticals, Inc. 25 Health Science Drive Stony Brook NY 11790 Generic Name: 6-alpha-ethylchenodeoxycholic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/9/2008 Date Approved Intercept Pharmaceuticals, Inc. 18 Desbrosses Street New York NY 10013 Generic Name: 6-hydroxymethylacylfulvene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/6/1999 Date Approved MGI Pharma, Inc. 5775 West Old Shakopee Suite 100 Bloomington MN 55437-3107 Generic Name: 8 Cyclopentyl 1,3-dipropylxanthine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/24/1997 Date Approved SciClone Pharmaceuticals, Inc. 901 Mariner's Island Boulevard San Mateo CA 94404-1593 Generic Name: 8-methoxsalen Trade Name (if present): Uvadex Date Designated 6/22/1993 Date Approved Designation Approved: Sponsor Contact Information Therakos, Inc. Oaklands Corporate Center 437 Creamery Way Exton PA 19341 Generic Name: 8-methoxsalen Trade Name (if present): Uvadex Date Designated 5/12/1994 Date Approved Designation Approved: Sponsor Contact Information Therakos, Inc. Oaklands Corporate Center 437 Creamery Way Exton PA 19341 Generic Name: 90Y-hPAMA4 Trade Name (if present): PAN-Cide Date Designated 1/29/2004 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: 9-cis-retinoic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/2/1997 Date Approved Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine CA 92623-9534 Generic Name: 9-nitro-20-(S)-camptothecin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/16/1996 Date Approved SuperGen, Inc. 4140 Dublin Blvd. Suite 200 Dublin CA 94568 Generic Name: 9-nitro-20-(S)-camptothecin Trade Name (if present): Camvirex Date Designated 5/15/2001 Date Approved Designation Approved: Treatment of pediatric HIV-infection/AIDS patients Sponsor Contact Information NovoMed Pharmaceuticals, Inc. P.O. Box 900 Germantown MD 20875-0900 Generic Name: a-(3-aminophthalimido) glutaramide Trade Name (if present): Actimid Date Designated 1/15/2003 Date Approved Designation Approved: Sponsor Contact Information Celgene Corporation 7 Powder Horn Drive Warren NJ 07059 Generic Name: A10 & AS2-1 Antineoplaston Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/3/2004 Date Approved Burzynski Research Institute, Inc. 9432 Old Katy Road Houston TX 77055 Generic Name: Abetimus Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/28/2000 Date Approved La Jolla Pharmaceutical Co. 6455 Nancy Ridge Dr. San Diego CA 92121 Generic Name: ACA125 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/25/2003 Date Approved Menarini Ricerche S.p.A. Via Tito Speri 10 Pomezia Roma ITALY Generic Name: Acetylcysteine Trade Name (if present): Mucomyst/Mucomyst 10 IV Date Designated 8/13/1987 Date Approved Designation Approved: Sponsor Contact Information Bristol-Myers Squibb Company P.O. Box 4500 Princeton NJ 08543-4500 Generic Name: acetylcysteine Trade Name (if present): Acetadote Date Designated 10/19/2001 Date Approved 1/23/2004 Designation Approved: For the use of Acetadote(registered TM) Injection, administered intravenously within 8 to 10 hours after ingestion of a potentially heptotoxic quantity of acetaminophen, to prevent or lessen hepatic injur Sponsor Contact Information Cumberland Pharmaceuticals, Inc. 209 10th Street South Suite 332 Nashville TN 37203 Generic Name: Acid sphingomyelinase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/2000 Date Approved Genzyme Corporation 500 Kendall Street Cambridge MA 02142 Generic Name: Aconiazide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/20/1988 Date Approved Lincoln Diagnostics P.O. Box 1128 Decatur IL 62525 Generic Name: Adalimumab Trade Name (if present): Humira Date Designated 10/19/2006 Date Approved Designation Approved: Sponsor Contact Information Abbott Laboratories 200 Abbott Park Road Abbott Park IL 60064-6188 Generic Name: Adalimumab Trade Name (if present): Humira Date Designated 3/21/2005 Date Approved 2/21/2008 Designation Approved: Treatment of Juvenile Idiopathic Arthritis Sponsor Contact Information Abbott Laboratories 200 Abbott Park Road Abbott Park IL 60064-6157 Generic Name: Adeno-associated vector expressing the human lipoprotein lipase protein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/21/2007 Date Approved Amsterdam Molecular Therapeutics BV P. O. Box 22506 NETHERLANDS Generic Name: Adeno-associated viral vector containing the gene for human coagulation factor IX Trade Name (if present): Coagulin-B Date Designated 6/13/2001 Date Approved Designation Approved: Sponsor Contact Information Avigen, Inc. 1301 Harbor Bay Parkway Alameda CA 94502 Generic Name: Adeno-associated viral vector containing the gene for human coagulation factor IX Trade Name (if present): Coagulin-B Date Designated 6/13/2001 Date Approved Designation Approved: Sponsor Contact Information Avigen, Inc. 1301 Harbor Bay Parkway Alameda CA 94502 Generic Name: Adeno-associated viral vector expressing human acid alpha glucosidase gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/20/2007 Date Approved Applied Genetic Technologies Corporation 11801 Research Drive Alachua FL 32615 Generic Name: adeno-associated viral vector expressing human retinoschisin-1 gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/21/2007 Date Approved Applied Genetic Technologies Corporation 11801 Research Drive Alachua FL 32615 Generic Name: Adeno-associated viral-based vector cystic fibrosis gene therapy Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/15/1995 Date Approved Targeted Genetics Corporation 1100 Olive Way, Suite 100 Seattle WA 98101 Generic Name: Adenosine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/1/1989 Date Approved Medco Research, Inc. 8455 Beverly Boulevard Suite 308 Los Angeles CA 90048 Generic Name: Adenoviral vector expressing Herpes simplex virus thymidine kinase gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/17/2005 Date Approved Advantagene, Inc. 160 Paulson Road Waban MA 02468 Generic Name: Adenovirus-based vector Factor VIII complementary DNA to somatic cells Trade Name (if present): MiniAdFVIII Date Designated 12/15/1999 Date Approved Designation Approved: Sponsor Contact Information GenStar Therapeutics Corporation 10835 Altman Row Suite 150 San Diego CA 92121 Generic Name: adenovirus-mediated herpes simplex virus-thymidine kinase gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/31/2001 Date Approved Ark Therapeutics Ltd 6 Warren Mews London W1T6AR London UNITED KINGDOM Generic Name: Aerosolized pooled immune globulin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/3/1989 Date Approved Pediatric Pharmaceuticals, Inc. 718 Bradford Avenue Westfield NJ 07090 Generic Name: a-Galactosidase A Trade Name (if present): Plant-Produced Human a-Glactosidase A Date Designated 1/21/2003 Date Approved Designation Approved: Sponsor Contact Information Alpha Gal. LLC 3333 Vacaville Parkway Suite 1000 Vacaville CA 95688 Generic Name: Aglycosyl anti-CD3 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/6/2006 Date Approved TolerRX, Inc. 300 Technology Square Cambridge MA 02139 Generic Name: AI-RSA Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/8/1992 Date Approved AutoImmune, Inc. 128 Spring Street Lexington MA 02173 Generic Name: Albendazole Trade Name (if present): Albenza Date Designated 1/18/1996 Date Approved 6/11/1996 Designation Approved: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. Sponsor Contact Information SmithKline Beecham Pharmaceuticals One Franklin Plaza P.O. Box 7929 Philadelphia PA 19101 Generic Name: Albendazole Trade Name (if present): Albenza Date Designated 1/17/1996 Date Approved 6/11/1996 Designation Approved: Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. Sponsor Contact Information SmithKline Beecham Pharmaceuticals One Franklin Plaza P.O. Box 7929 Philadelphia PA 19101 Generic Name: Albuterol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/12/2002 Date Approved MotoGen, Inc. 3 Pine View Road Mount Kisco NY 10549 Generic Name: Aldesleukin Trade Name (if present): Proleukin Date Designated 3/22/1989 Date Approved Designation Approved: Sponsor Contact Information Chiron Corporation 4560 Horton Street Emeryville CA 94608-2916 Generic Name: Aldesleukin Trade Name (if present): Proleukin Date Designated 9/14/1988 Date Approved 5/5/1992 Designation Approved: Treatment of adults (>18 years old) with metastatic renal cell carcinoma. Sponsor Contact Information Chiron Corporation 4560 Horton Street Emeryville CA 94608-2916 Generic Name: Aldesleukin Trade Name (if present): Proleukin Date Designated 9/10/1996 Date Approved 1/9/1998 Designation Approved: Treatment of adults with metastatic melanoma. Sponsor Contact Information Chiron Corporation 4560 Horton Street Emeryville CA 94608-2916 Generic Name: Aldesleukin Trade Name (if present): Proleukin Date Designated 7/31/1998 Date Approved Designation Approved: Sponsor Contact Information Chiron Corporation 4560 Horton St. Emeryville CA 94608-2916 Generic Name: Aldesleukin Trade Name (if present): Proleukin Date Designated 11/24/1998 Date Approved Designation Approved: Sponsor Contact Information Chiron Corporation 4560 Horton St. Emeryville CA 94608-2916 Generic Name: Alefacept Trade Name (if present): Amevive Date Designated 12/19/2007 Date Approved Designation Approved: Sponsor Contact Information Astellas Pharma US, Inc. Three Parkway North Deerfield IL 60015-2548 Generic Name: alemtuzumab Trade Name (if present): Campath Date Designated 10/20/1997 Date Approved 5/7/2001 Designation Approved: The treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy. Sponsor Contact Information Genzyme Corporation 4545 Horizon Hill Blvd. San Antonio TX 78229-2263 Generic Name: alendronate Trade Name (if present): Fosamax Date Designated 3/31/2003 Date Approved Designation Approved: Sponsor Contact Information Merck & Co., Inc. 126 East Lincoln Ave. Rahway NJ 07065-0900 Generic Name: Alendronate disodium Trade Name (if present): Fosamax Date Designated 2/13/2001 Date Approved Designation Approved: Sponsor Contact Information Richard J. Wenstrup, M.D. Division of Human Genetics Children's Hospital Research Foundation Cincinnati OH 45229-3039 Generic Name: Alfentanil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/8/2005 Date Approved Cinergen, LLC 146 Medinah Drive Blue Bell PA 19422-3212 Generic Name: Alfentanil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/9/2005 Date Approved Cinergen, LLC 146 Medinah Drive Blue Bell PA 19422-3212 Generic Name: Alglucerase injection Trade Name (if present): Ceredase Date Designated 7/21/1995 Date Approved Designation Approved: Sponsor Contact Information Genzyme Corporation One Kendall Square Cambridge MA 02139-1562 Generic Name: Alglucerase injection Trade Name (if present): Designation Approved: Long-term enzyme replacement therapy for children, adolescents and adult patients with a confirmed diagnosis of Type I Gaucher disease who exhibit signs and symptoms that are severe enough to result in one or more of the following conditions: a) moderate-to-severe anemia; b) thrombocytopenia with bleeding tendency; c) bone disease; d) significant hepatomegaly or splenomegaly. Ceredase Date Designated 3/11/1985 Date Approved 4/5/1991 Sponsor Contact Information Genzyme Corporation One Kendall Square Cambridge MA 02139-1562 Generic Name: Alitretinoin Trade Name (if present): Panretin Date Designated 3/24/1998 Date Approved 2/2/1999 Designation Approved: Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma. Sponsor Contact Information Eisai Medical Research, Inc 55 Challenger Road Ridgefield Park NJ 07660 Generic Name: Alitretinoin Trade Name (if present): Panretin Date Designated 4/10/1992 Date Approved Designation Approved: Sponsor Contact Information Ligand Pharmaceuticals, Inc. 10275 Science Center Dr. San Diego CA 92121-1117 Generic Name: allantoin Trade Name (if present): Alwextin Date Designated 11/21/2002 Date Approved Designation Approved: Sponsor Contact Information Alwyn Company, Inc. 2301 Highway 60 East Lake Crystal MN 56055 Generic Name: Allogeneic human retinal pigment epithelial cells on gelatin microcarriers Trade Name (if present): Spheramine Date Designated 7/18/1997 Date Approved Designation Approved: Sponsor Contact Information Bayer Healthcare Pharmaceuticals, Inc. Post Office Box 1000 50 Division Street, Suite 503 Montville NJ 07045-1000 Generic Name: Allogeneic peripheral blood mononuclear cells sensitized against patient alloantigens by mixed lymphocyte culture Trade Name (if present): CYTOIMPLANT Date Designated 6/13/1997 Date Approved Designation Approved: Sponsor Contact Information Applied Immunotherapeutics, LLC 14132 E. Firestone Boulevard Santa Fe Springs CA 90670 Generic Name: Allogeneic retinal epithelial cells transfected with plasmid vector expressing ciliary neurotrophic growth Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/1/2004 Date Approved Neurotech USA, Inc. 6 Blackstone Valley Place Lincoln RI 02865 Generic Name: Allogeneic T-cells cultured with anti-CD3 and IL-2; transduced with retroviral vector (SFCMM-3), expressing herpes simplex 1 virus-thymidine kinase (HSV-TK) and truncated low affinity nerve growth factor receptor; selected with anti-low affinity nerve gro Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/28/2005 Date Approved MolMed S.p.A. Via Olgettina 58 Milan 20132 ITALY Generic Name: Allopurinol riboside Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/4/1985 Date Approved Burroughs Wellcome Company 3030 Cornwallis Road P.O. Box 12700 Research Triangle Park NC 27709 Generic Name: Allopurinol riboside Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/4/1985 Date Approved Burroughs Wellcome Company 3030 Cornwallis Road P.O. Box 12700 Research Triangle Park NC 27709 Generic Name: Allopurinol sodium Trade Name (if present): Aloprim for Injection Date Designated 10/16/1992 Date Approved 5/17/1996 Designation Approved: Management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. Sponsor Contact Information Catalytica Pharmaceuticals, Inc PO Box 1887 Greenville NC 27835-1887 Generic Name: Allopurinol sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/9/1987 Date Approved Burroughs Wellcome Company 3030 Cornwallis Road Research Triangle Pk NC 27709 Generic Name: Alpha-1-acid glycoprotein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/5/2004 Date Approved Bio Products Laboratory Dagger Lane, Elstree, Hertfordshire WD6 3BX UNITED KINGDOM Generic Name: Alpha-1-acid glycoprotein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/17/2004 Date Approved Bio Products Laboratory Dagger Lane Elstree, Hertfordshire UNITED KINGDOM Generic Name: Alpha-1-antitrypsin (recombinant DNA Origin) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/1/1984 Date Approved Chiron Corporation 4560 Horton Street Emeryville CA 94608-2916 Generic Name: Alpha1-antitrypsin(human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/3/2008 Date Approved Kamada, Ltd. 7 Sapir Street Ness Ziona ISRAEL Generic Name: Alpha1-Proteinase Inhibitor (Human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/22/2004 Date Approved Kamada Ltd. Kiryat Weizmann ISRAEL Generic Name: Alpha1-Proteinase Inhibitor (Human) Trade Name (if present): ARC-API Date Designated 9/1/2004 Date Approved Designation Approved: Sponsor Contact Information Kamada Ltd. Kiryat Weizmann ISRAEL Generic Name: Alpha1-proteinase inhibitor (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/24/1999 Date Approved CSL Behring L.L.C. 1020 First Ave. PO Box 61501 King of Prussia PA 19406-0901 Generic Name: Alpha1-proteinase inhibitor (human) Trade Name (if present): Prolastin Date Designated 12/7/1984 Date Approved 12/2/1987 Designation Approved: For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema. Sponsor Contact Information Bayer Corporation Pharmaceutical Division, Biological Products 400 Morgan Lane New Haven CT 06516 Generic Name: Alpha-galactosidase A Trade Name (if present): Fabrase Date Designated 7/20/1990 Date Approved Designation Approved: Sponsor Contact Information Desnick, Robert J. M.D. The Mount Sinai School Of Medicine Fifth Avenue at 100th Street, Box 1203 New York NY 10029 Generic Name: Alpha-galactosidase A Trade Name (if present): CC-galactosidase Date Designated 6/17/1991 Date Approved Designation Approved: Sponsor Contact Information David Calhoun, Ph.D. Department of Chemistry Convent Avenue & 138th Street New York NY 10031 Generic Name: Alpha-galactosidase A Trade Name (if present): Replagal Date Designated 6/22/1998 Date Approved Designation Approved: Sponsor Contact Information Shire Human Genetic Therapies, Inc. 700 Main Street Cambridge MA 02139 Generic Name: Alpha-melanocyte stimulating hormone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/19/1997 Date Approved National Institute of Diabetes, and Digestive and Kidney Diseases National Institutes of Health, 31 Center Drive MSC Building 31, Room 9N-222 Bethesda MD 20892-2560 Generic Name: Alpha-tocopherol quinone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/28/2006 Date Approved Penwest Pharmaceuticals Company 39 Old Ridgebury Road Suite 11 Danbury CT 06810 Generic Name: Alprostadil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/20/1993 Date Approved Schwarz Pharma, Inc. P.O. Box 2038 Milwaukee WI 53201 Generic Name: alteplase Trade Name (if present): Activase Date Designated 1/27/2003 Date Approved Designation Approved: Sponsor Contact Information Daniel F. Hanley, MD Johns Hopkins University 600 N. Wolfe St., Jefferson 1-109 Baltimore MD 21287 Generic Name: Altretamine Trade Name (if present): Hexalen Date Designated 2/9/1984 Date Approved 12/26/1990 Designation Approved: Single agent palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent based combination. Sponsor Contact Information Medimmune Oncology, Inc. One Tower Bridge 100 Front Street, Suite 400 Conshohocken PA 19428 Generic Name: Alvocidib Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/13/2007 Date Approved Sanofi-Aventis US, Inc. 55 Corporate Drive Bridgewater NJ 08807 Generic Name: ambrisentan Trade Name (if present): Letairis Date Designated 7/16/2004 Date Approved 6/15/2007 Designation Approved: Treatment of pulmonary arterial hypertension (WHO group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening Sponsor Contact Information Gilead Colorado 7575 West 103rd Avenue Suite 102 Westminister CO 80021-5426 Generic Name: AMG 531 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/31/2007 Date Approved Amgen Inc. One Amgen Center Drive Thousand Oaks CA 91320-1799 Generic Name: AMG 531 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/27/2003 Date Approved Amgen, Inc. One Amgen Center Drive Thousand Oaks CA 91320-1799 Generic Name: Amifostine Trade Name (if present): Ethyol Date Designated 10/4/1999 Date Approved Designation Approved: Sponsor Contact Information Medimmune Oncology, Inc. One MedImmune Way Gaithersburg MD 20878 Generic Name: Amifostine Trade Name (if present): Ethyol Date Designated 5/30/1990 Date Approved Designation Approved: Sponsor Contact Information Medimmune LLC One MedImmune Way Gaithersburg MD 20878 Generic Name: Amifostine Trade Name (if present): Ethyol Date Designated 5/30/1990 Date Approved Designation Approved: Sponsor Contact Information Medimmune, LLC One MedImmune Way Gaithersburg MD 20878 Generic Name: Amifostine Trade Name (if present): Ethyol Date Designated 5/30/1990 Date Approved 12/8/1995 Designation Approved: To reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. Sponsor Contact Information Medimmune Oncology, Inc. One Tower Bridge 100 Front Street, Suite 400 West Conshohocken PA 19428 Generic Name: Amifostine Trade Name (if present): Ethyol Date Designated 5/12/1998 Date Approved 6/24/1999 Designation Approved: Reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. Sponsor Contact Information Medimmune Oncology, Inc. One Tower Bridge 100 Front Street, Suite 400 Conshohocken PA 19428 Generic Name: Amifostine Trade Name (if present): Ethyol Date Designated 11/24/1998 Date Approved Designation Approved: Sponsor Contact Information Medimmune LLC One MedImmune Way Gaithersburg MD 20878 Generic Name: Amikacin Trade Name (if present): SLIT Amikacin Date Designated 3/9/2006 Date Approved Designation Approved: Sponsor Contact Information Transave, Inc. 11 Deer Park Drive Monmouth Junction NJ 08852-1923 Generic Name: Amiloride HCl solution for inhalation Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/18/1990 Date Approved Glaxo Wellcome Research and Development 5 Moore Drive PO Box 13398 Research Triangle Park NC 27709 Generic Name: Aminocaproic acid Trade Name (if present): Caprogel Date Designated 1/6/1995 Date Approved Designation Approved: Sponsor Contact Information Eastern Virginia Medical School Department of Ophthalomology 880 Kempsville Road, Suite 2500 Norfolk VA 23502-3990 Generic Name: Aminolevlinic acid hydrochloride Trade Name (if present): Levulan Date Designated 3/20/2007 Date Approved Designation Approved: Sponsor Contact Information DUSA Pharmaceuticals, Inc. 25 Upton Drive Wilmington MA 01887 Generic Name: Aminosalicylate sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/6/1993 Date Approved Syncom Pharmaceuticals, Inc. 66 Hanover Road Florham Park NJ 07932 Generic Name: Aminosalicylic acid Trade Name (if present): Paser Granules Date Designated 2/19/1992 Date Approved 6/30/1994 Designation Approved: Treatment of tuberculosis Sponsor Contact Information Jacobus Pharmaceutical Company 37 Cleveland Lane P.O. Box 5290 Princeton NJ 08540 Generic Name: Aminosidine Trade Name (if present): Paromomycin Date Designated 3/29/2005 Date Approved Designation Approved: Sponsor Contact Information The Institute for One World Health 580 California Street San Francisco CA 94104 Generic Name: Aminosidine Trade Name (if present): Paromomycin Date Designated 9/9/1994 Date Approved Designation Approved: Sponsor Contact Information Kanyok, Thomas P. Pharm.D. University of Illinois at Chicago College of Pharm 833 South Wood Street (m/c886) Rm. 176 Chicago IL 60612 Generic Name: Aminosidine Trade Name (if present): Gabbromicina Date Designated 5/14/1993 Date Approved Designation Approved: Sponsor Contact Information Kanyok, Thomas P. Pharm.D. University Of Illinois At Chicago College of Pharm 833 South Wood Street (m/c886) Rm. 176 Chicago IL 60612 Generic Name: Aminosidine Trade Name (if present): Gabbromicina Date Designated 11/15/1993 Date Approved Designation Approved: Sponsor Contact Information Kanyok, Thomas P. Pharm.D. University of Illinois at Chicago College of Pharm 833 South Wood Street (m/c886) Rm. 176 Chicago IL 60612 Generic Name: Amiodarone Trade Name (if present): Amio-Aqueous Date Designated 8/17/1993 Date Approved Designation Approved: Sponsor Contact Information Academic Pharmaceuticals, Inc. 21 N. Skokie Valley Highway Suite G3 Lake Bluff IL 60044 Generic Name: Amiodarone HCl Trade Name (if present): Cordarone Date Designated 3/16/1994 Date Approved 8/3/1995 Designation Approved: For initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Sponsor Contact Information Wyeth-Ayerst Laboratories P.O. Box 8299 Philadelphia PA 19101 Generic Name: Ammonium tetrathiomolybdate Trade Name (if present): Coprexa Date Designated 1/31/1994 Date Approved Designation Approved: Sponsor Contact Information Pipex Pharmaceuticals, Inc. 3930 Varsity Drive Ann Arbor MI 48108 Generic Name: Amonafide L-malate Trade Name (if present): Xanafide Date Designated 12/20/2006 Date Approved Designation Approved: Sponsor Contact Information Xanthus Pharmaceuticals, Inc. 300 Technology Square Cambridge MA 02139 Generic Name: Amphotericin B inhalation powder Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/15/2005 Date Approved Nektar Therapeutics 201 Industrial Road San Carlos CA 94070-6256 Generic Name: Amphotericin B lipid complex Trade Name (if present): Abelcet Date Designated 8/21/1996 Date Approved Designation Approved: Sponsor Contact Information The Liposome Company, Inc. One Research Way Princeton NJ 08540 Generic Name: Amphotericin B lipid complex Trade Name (if present): Abelcet Date Designated 9/23/1996 Date Approved Designation Approved: Sponsor Contact Information The Liposome Company, Inc. One Research Way Princeton NJ 08540 Generic Name: Amphotericin B lipid complex Trade Name (if present): Abelcet Date Designated 5/6/1996 Date Approved Designation Approved: Sponsor Contact Information The Liposome Company, Inc. One Research Way Princeton NJ 08540 Generic Name: Amphotericin B lipid complex Trade Name (if present): Abelcet Date Designated 5/6/1996 Date Approved Designation Approved: Sponsor Contact Information The Liposome Company, Inc. One Research Way Princeton NJ 08540 Generic Name: Amphotericin B lipid complex Trade Name (if present): Abelcet Date Designated 6/27/1996 Date Approved Designation Approved: Sponsor Contact Information The Liposome Company, Inc. One Research Way Princeton NJ 08540 Generic Name: Amphotericin B lipid complex Trade Name (if present): Abelcet Date Designated 12/5/1991 Date Approved 10/18/1996 Designation Approved: Treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. Sponsor Contact Information Liposome Company, Inc. One Research Way Princeton NJ 08540 Generic Name: amrubicin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/10/2008 Date Approved Pharmion Corporation 2525 28th Street Boulder CO 80301 Generic Name: Amsacrine Trade Name (if present): Amsidyl Date Designated 12/7/1984 Date Approved Designation Approved: Sponsor Contact Information Warner-Lambert Company Parke-Davis Pharmaceutical Research Division 2800 Plymouth Road Ann Arbor MI 48106 Generic Name: Amyl nitrite, sodium nitrite, sodium thiosulfate Trade Name (if present): Cyanide Antidote Kit Date Designated 12/18/2006 Date Approved Designation Approved: Sponsor Contact Information Akorn, Inc. 2500 Millbrook Drive Buffalo Grove IL 60089 Generic Name: Anagrelide Trade Name (if present): Agrylin Date Designated 7/14/1986 Date Approved Designation Approved: Sponsor Contact Information Roberts Pharmaceutical Corp. Meridian Center II 4 Industrial Way West Eatontown NJ 07724-2274 Generic Name: Anagrelide Trade Name (if present): Agrylin Date Designated 1/27/1988 Date Approved 3/14/1997 Designation Approved: Treatment of patients with essential thrombocythemia to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms. Sponsor Contact Information Roberts Pharmaceutical Corp. Meridian Center III 6 Industrial Way West Eatontown NJ 07724 Generic Name: Anagrelide Trade Name (if present): Agrylin Date Designated 6/11/1985 Date Approved Designation Approved: Sponsor Contact Information Roberts Pharmaceutical Corp. Meridian Center II 4 Industrial Way West Eatontown NJ 07724-2274 Generic Name: Ananain, comosain Trade Name (if present): Vianain Date Designated 1/21/1992 Date Approved Designation Approved: Sponsor Contact Information Genzyme Corporation One Kendall Square Cambridge MA 02139 Generic Name: Anaritide acetate Trade Name (if present): Auriculin Date Designated 8/27/1992 Date Approved Designation Approved: Sponsor Contact Information Scios, Inc. 2450 Bayshore Parkway Mountain View CA 94043 Generic Name: Anaritide acetate Trade Name (if present): Auriculin Date Designated 4/10/1992 Date Approved Designation Approved: Sponsor Contact Information Scios, Inc. 2450 Bayshore Parkway Mountain View CA 94043 Generic Name: Anatibant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/15/2005 Date Approved Xytis, Inc. 400 South El Camino Real Suite 1200 San Mateo CA 94402-1703 Generic Name: Ancrod Trade Name (if present): Viprinex Date Designated 10/20/1989 Date Approved Designation Approved: Sponsor Contact Information Knoll Pharmaceutical Company 3000 Continental Dr., North Mt. Olive NJ 07828 Generic Name: Angiotensin 1-7 Trade Name (if present): MARstem Date Designated 8/3/2001 Date Approved Designation Approved: Sponsor Contact Information Maret Pharmaceutical Corporation 4041 MacArthur Boulevard, Suite 375 Newport Beach CA 92660 Generic Name: Angiotensin 1-7 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/16/2000 Date Approved Maret Pharmaceuticals 4041 MacArthur Blvd. Suite 375 Newport Beach CA 92660 Generic Name: Anti pan T lymphocyte monoclonal antibody Trade Name (if present): Anti-t Lymphocyte Immunotoxin Xmmlyh65-rta Date Designated 1/29/1986 Date Approved Designation Approved: Sponsor Contact Information Xoma Corporation 2910 Seventh Street Berkeley CA 94710 Generic Name: Anti pan T lymphocyte monoclonal antibody Trade Name (if present): Anti-t Lymphocyte Immunotoxin Xmmlyh65-rta Date Designated 1/29/1986 Date Approved Designation Approved: Sponsor Contact Information Xoma Corporation 2910 Seventh Street Berkeley CA 94710 Generic Name: antiangiogenic components extracted from marine cartilage Trade Name (if present): Neovastat (AE-941) Date Designated 10/16/2002 Date Approved Designation Approved: Sponsor Contact Information AEterna Zentaris, Inc. Dr. Claude Hariton Chief Medical Officer, VP, Cli Quebec G1P 4P5, Canada CANADA Generic Name: anti-CD23 IgG1, kappa monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/12/2003 Date Approved Biogen IDEC, Inc. 5200 Research Place San Diego CA 92122 Generic Name: Anti-CD40 mAb Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/6/2005 Date Approved Seattle Genetics, Inc. 21823 30th Drive Southeast Bothell WA 98021 Generic Name: Anti-CD45 monoclonal antibodies Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/10/1990 Date Approved Baxter Healthcare Corporation 1620 Waukegan Road Mcgaw Park IL 60085 Generic Name: Anti-CEA Sheep-human chimeric monoclonal antibody labeled w/iodine-131 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/21/2003 Date Approved Xenova Biomedix Limited CELTIC PHARMA 957 Buckingham Avenue Berkshire SL1 4NL UNITED KINGDOM Generic Name: Anti-cytomegalovirus monoclonal antibodies Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/2/1990 Date Approved Biomedical Research Institute 345 North Smith Avenue St. Paul MN 55102 Generic Name: Anti-cytomegalovirus monoclonal antibodies Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/2/1990 Date Approved Biomedical Research Institute 345 North Smith Avenue St. Paul MN 55102 Generic Name: Anti-cytomegalovirus monoclonal antibodies Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/3/1990 Date Approved Biomedical Research Institute 345 North Smith Avenue St. Paul MN 55102 Generic Name: Anti-cytomegalovirus monoclonal antibodies Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/3/1990 Date Approved Biomedical Research Institute 345 North Smith Avenue St. Paul MN 55102 Generic Name: Anti-cytotoxic T lymphocyte antigen 4 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/18/2006 Date Approved Pfizer Global Research & Development 50 Pequot Avenue New London CT 06320 Generic Name: Antiepilepsirine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/23/1989 Date Approved Children's Hospital 700 Children's Drive Columbus OH 43205 Generic Name: Antihemophilic factor (human) Trade Name (if present): Alphanate Date Designated 1/5/1996 Date Approved 1/31/2007 Designation Approved: For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery Sponsor Contact Information Grifols Biologicals Inc. 5555 Valley Boulevard Los Angeles CA 90032-3548 Generic Name: Antihemophilic factor (recombinant) Trade Name (if present): ReFacto Date Designated 2/8/1996 Date Approved 1/1/9999 Designation Approved: Sponsor Contact Information Wyeth Pharmaceuticals, Inc. P. O. Box 8299 Philadelphia PA 19101-8299 Generic Name: Antihemophilic factor (recombinant) Trade Name (if present): Kogenate Date Designated 9/25/1989 Date Approved 2/25/1993 Designation Approved: Treatment and prophylaxis of bleeding in patients with hemophilia A (not von Willebrand's disease) Sponsor Contact Information Bayer Corporation 1884 Miles Avenue Elkhart IN 46515 Generic Name: Antihemophilic factor/von Willebrand factor complex (human), dried, pasteurized Trade Name (if present): Humate-P Date Designated 10/16/1992 Date Approved 4/1/1999 Designation Approved: (1) In adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and (2) in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate. Sponsor Contact Information Aventis Behring L.L.C. 1020 First Avenue PO Box 61501 King Of Prussia PA 19406-0901 Generic Name: anti-interferon-gamma Fab from goats Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/18/2003 Date Approved Advanced Biotherapy, Inc. 6355 Topanga Canyon Blvd. Suite 510 Woodland Hills CA 91367 Generic Name: Antimelanoma Antibody XMMME-001-DTPA 111 Indium Trade Name (if present): Antimelanoma Antibody XMMME-001DTPA 111 Indium Date Designated 11/14/1984 Date Approved Designation Approved: Sponsor Contact Information Xoma Corporation 2910 Seventh Street Berkeley CA 94710 Generic Name: Antimelanoma Antibody XMMME-001-RTA Trade Name (if present): Antimelanoma Antibody XMMME-001RTA Date Designated 11/14/1984 Date Approved Designation Approved: Sponsor Contact Information Xoma Corporation 2910 Seventh Street Berkeley CA 94710 Generic Name: Antipyrine Test Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/21/1985 Date Approved Upsher-Smith Laboratories, Inc 4905 23rd Avenue North Minneapolis MN 55447 Generic Name: Antisense 20-mer oligonucleotide complementary to R2 component of ribonucleotide reductase mRNA Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/15/2005 Date Approved Lorus Therapeutics, Inc. 2 Meridan Road M9W 4Z7 CANADA Generic Name: antisense 20-mer phosphorothioate oligonucleotide [complementary to the coding region of R2 component of the human ribonucleotide reductase mRNA] Trade Name (if present): GTI-2040 Date Designated 3/12/2003 Date Approved Designation Approved: Sponsor Contact Information Lorus Therapeutics, Inc 2 Meridan Road M9W427 CANADA Generic Name: Antisense inhibitor of apoB-100 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/23/2006 Date Approved Isis Pharmaceuticals, Inc. 1896 Rutherford ?Road Carlbad CA 92008 Generic Name: Anti-tap-72 immunotoxin Trade Name (if present): Xomazyme-791 Date Designated 3/6/1987 Date Approved Designation Approved: Sponsor Contact Information Xoma Corporation 2910 Seventh Street Berkeley CA 94710 Generic Name: Anti-tenascin 81C6 monoclonal antibody labeled w/ I 131 Trade Name (if present): Neuradiab Date Designated 10/4/2005 Date Approved Designation Approved: Sponsor Contact Information Bradmer Pharmaceuticals, Inc. 9900 Corporate Campus Drive Suite 3000 Louisville KY 40223 Generic Name: Antithrombin III (human) Trade Name (if present): ATnativ Date Designated 2/8/1985 Date Approved 12/13/1989 Designation Approved: Sponsor Contact Information Pharmacia & Upjohn AB Lindhagensgatan 133 SE-112 87 SWEDEN Generic Name: Antithrombin III (human) Trade Name (if present): Thrombate III Date Designated 11/26/1984 Date Approved 12/30/1991 Designation Approved: Sponsor Contact Information Bayer Corporation Pharmaceutical Division, Biological Products 400 Morgan Lane New Haven CT 06516 Generic Name: Antithrombin III (human) concentrate IV Trade Name (if present): Kybernin P Date Designated 7/2/1985 Date Approved Designation Approved: Sponsor Contact Information CSL Behring 1020 First Ave. PO Box 61501 King of Prussia PA 19406-0901 Generic Name: Antithrombin III human Trade Name (if present): Antithrombin III human Date Designated 1/2/1986 Date Approved Designation Approved: Sponsor Contact Information American National Red Cross 9312 Old Georgetown Road Bethesda MD 20814 Generic Name: Anti-thymocyte Globulin (Rabbitt) Trade Name (if present): Thymoglobulin Date Designated 9/6/2000 Date Approved Designation Approved: Sponsor Contact Information Genzyme Corporation 500 Kendall Street Cambridge MA 02142 Generic Name: Anti-thymocyte serum Trade Name (if present): Nashville Rabbit Anti-thymocyte Serum Date Designated 6/2/1993 Date Approved Designation Approved: Sponsor Contact Information Applied Medical Research 1600 Hayes Street Nashville TN 37203 Generic Name: Antivenin crotaline (pit-viper) equine immune F(ab)2) Trade Name (if present): Antivipmyn Date Designated 1/29/2004 Date Approved Designation Approved: Sponsor Contact Information Rare Disease Therapeutics, Inc. 1101 Kermit Drive, Suite 608 Nashville TN 37217 Generic Name: Antivenin, crotalidae polyvalent immune Fab (ovine) Trade Name (if present): CroFab Date Designated 1/12/1994 Date Approved 10/2/2000 Designation Approved: Carol Clark-Evans direct line (615) 963-4510 Sponsor Contact Information Protherics, Inc. 1207 17th Ave. S., Suite 103 Nashville TN 37212 Generic Name: Antivenom (crotalidae) purified (avian) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/12/1991 Date Approved Ophidian Pharmaceuticals, Inc. 5445 East Cheryl Parkway Madison WI 53711 Generic Name: Anti-von Willebrand Aptamer Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/9/2008 Date Approved Archemix Corporation 300 Third Street Cambridge MA 02142 Generic Name: AP1903 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/24/1999 Date Approved Ariad Pharmaceuticals, Inc. 26 Landsdowne St. Cambridge MA 02139-4234 Generic Name: APL 400-020 V-Beta DNA vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/8/1995 Date Approved Wyeth-Lederle Vaccines and Pediatrics 211 Bailey Rd. West Henrietta NY 14586-9728 Generic Name: Apomorphine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/20/1997 Date Approved Scherer DDS Frankland Road Swindon SN5 8RU Wiltshire UNITED KINGDOM Generic Name: Apomorphine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/17/1995 Date Approved Pentech Pharmaceuticals, Inc. 1110 Lake Cook Rd. Suite 257 Buffalo Grove IL 60089 Generic Name: Apomorphine HCl Trade Name (if present): Apokyn Date Designated 4/22/1993 Date Approved 4/20/2004 Designation Approved: For the acute, intermittent treatment of hypomobility, "off" episodes ("endof-dose-wearing-off" and unpredictable :on/off" episodes) associated with advanced Parkinson's disease Sponsor Contact Information Vernalis R & D Ltd Oakdene Court Winnersh, Berkshire RG41 5UA UNITED KINGDOM Generic Name: Apomorphine hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/23/2006 Date Approved NeuroHealing Pharmaceuticals, Inc. 50 Undine Road Newton MA 02135 Generic Name: Aprotinin Trade Name (if present): Trasylol Date Designated 11/17/1993 Date Approved 12/29/1993 Designation Approved: Sponsor Contact Information Bayer Corporation Pharmaceutical Division 400 Morgan Lane West Haven CT 06516 Generic Name: Arcitumomab Trade Name (if present): 99m Tc-labeled CEA-Scan Date Designated 5/10/1996 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Arginine butyrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/25/1994 Date Approved Vertex Pharmaceuticals Inc. 130 Waverly Street Cambridge MA 02139-4242 Generic Name: Arginine butyrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/7/1992 Date Approved Perrine, Susan P., M.D. Boston University Cancer Research Center Boston MA 02118 Generic Name: arimoclomol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/29/2005 Date Approved CytRx Corporation 3030 Bunker Hill Street Suite 105 San Diego CA 92109 Generic Name: Aripiprazole Trade Name (if present): Abilify Date Designated 1/25/2006 Date Approved Designation Approved: Sponsor Contact Information Floyd R. Sallee, M.D., Ph.D. University of Cincinnati School of Medicine/ P. O. Box 670669 231 Albert Sabin Way Cincinnati OH 45267-0559 Generic Name: arsenic Trade Name (if present): Trisenox Date Designated 11/2/2001 Date Approved Designation Approved: Sponsor Contact Information Cephalon, Inc. 41 Moores Road Frazer PA 19355 Generic Name: Arsenic trioxide Trade Name (if present): Trisenox Date Designated 3/4/2005 Date Approved Designation Approved: Sponsor Contact Information Cephalon Inc 41 Moores Road Frazer PA 19355 Generic Name: arsenic trioxide Trade Name (if present): Trisenox Date Designated 10/18/2001 Date Approved Designation Approved: Sponsor Contact Information Cephalon, Inc. 41 Moores Road Frazer PA 19355 Generic Name: Arsenic trioxide Trade Name (if present): Trisenox Date Designated 3/3/1998 Date Approved 9/25/2000 Designation Approved: For induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation of PML/RAR-alpha gene Sponsor Contact Information Cell Therapeutics, Inc. 201 Elliott Ave. West Suite 400 Seattle WA 98119 Generic Name: Arsenic trioxide Trade Name (if present): Trisenox Date Designated 4/28/2000 Date Approved Designation Approved: Sponsor Contact Information Cephalon, Inc. 41 Moores Road Frazer PA 19355 Generic Name: arsenic trioxide Trade Name (if present): Trisenox Date Designated 6/13/2003 Date Approved Designation Approved: Sponsor Contact Information Cephalon, Inc. 41 Moores Road Frazer PA 19355 Generic Name: Arsenic trioxide Trade Name (if present): Trisenox Date Designated 5/13/2003 Date Approved Designation Approved: Sponsor Contact Information Cephalon, Inc. 41 Moores Road Frazer PA 19355 Generic Name: arsenic trioxide Trade Name (if present): Trisenox Date Designated 7/17/2000 Date Approved Designation Approved: Sponsor Contact Information Cephalon, Inc. 41 Moores Road P.O. Box 4011 Frazer PA 19355 Generic Name: artemether/lumefantrine Trade Name (if present): Coartem Date Designated 8/31/2007 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaceuticals Bldg 405/4051 One Health Plaza East Hanover NJ 07936-1080 Generic Name: Artesunate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/28/2006 Date Approved US Army Medical Materiel Development Activity Office of the Surgeon General 622 Neiman Street Ft. Detrick MD 21702-9240 Generic Name: Artesunate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/19/1999 Date Approved World Health Organization Special Programme for Research and Training in Tro Via Appia , Geneva 27 Generic Name: arylsulfatase A (rhARSA) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/27/2008 Date Approved Shire Human Genetic Therapies, Inc. 700 Main Street Cambridge MA 02139 Generic Name: As-101 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/9/1987 Date Approved NPDC-AS101, Inc. 783 Jersey Avenue New Brunswick NJ 08901 Generic Name: Ascorbic acid Trade Name (if present): Ascor L 500 Date Designated 8/31/2007 Date Approved Designation Approved: Sponsor Contact Information McGuff Pharmaceuticals Inc. 2921 W. McArthur Blvd. Santa Ana CA 92704-6929 Generic Name: Atomoxetine hydrochloride Trade Name (if present): STRATTERA Date Designated 8/26/2003 Date Approved Designation Approved: Sponsor Contact Information Eli Lilly & Company Lilly Corporate Center Indianapolis IN 46285 Generic Name: Atovaquone Trade Name (if present): Mepron Date Designated 8/14/1991 Date Approved 1/5/1999 Designation Approved: Prevention of PCP in patients who are intolerant to trimethoprimsulfamethoxazole. Sponsor Contact Information Glaxo Wellcome Research and Development 5 Moore Drive PO Box 13398 Research Triangle Park NC 27709 Generic Name: Atovaquone Trade Name (if present): Mepron Date Designated 9/10/1990 Date Approved 11/25/1992 Designation Approved: For the acute oral treatment of mild to moderate Pneumocystis carinii pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole. Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Atovaquone Trade Name (if present): Mepron Date Designated 3/16/1993 Date Approved Designation Approved: Sponsor Contact Information GlaxoSmithKline, Inc. 5 Moore Drive PO Box 13398 Research Triangle Park NC 27709 Generic Name: Atovaquone Trade Name (if present): Mepron Date Designated 3/16/1993 Date Approved Designation Approved: Sponsor Contact Information GlaxoSmithKline, Inc. 5 Moore Drive PO Box 13398 Research Triangle Park NC 27709-3398 Generic Name: Attenuated autologous cancer cells and granulocyte macrophage colony stimulating factor in combination with activated autologous blood derived T-cells Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/27/2007 Date Approved TVAX Biomedical, LLC 8060 Reeder Street Lenexa KS 66214-1554 Generic Name: augmerosen Trade Name (if present): Genasense Date Designated 8/28/2001 Date Approved Designation Approved: Sponsor Contact Information Genta Inc. Two Connell Drive Berkeley Heights NJ 07922 Generic Name: augmerosen Trade Name (if present): Genasense Date Designated 8/28/2001 Date Approved Designation Approved: Sponsor Contact Information Genta, Inc. Two Connell Drive Berkeley Heights NJ 07922 Generic Name: augmerosen Trade Name (if present): Genasense Date Designated 8/28/2001 Date Approved Designation Approved: Sponsor Contact Information Genta, Inc, Two Connell Drive Berkeley Heights NJ 07922 Generic Name: autologous antigen presenting cells pulsed with autologous tumor Ig idiotype Trade Name (if present): Mylovenge Date Designated 4/18/2002 Date Approved Designation Approved: Sponsor Contact Information Dendreon Corporation 3005 First Avenue Seattle WA 98121 Generic Name: Autologous cultured endothelial cells on a donor human corneal disk Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/1/2007 Date Approved Cellular Bioengineering, Inc. 1946 Young Street Honolulu HI 96826 Generic Name: Autologous dendritic cells pulsed with autologous antigens from primay malignant brain tumor cells Trade Name (if present): DCVax-Brain Date Designated 11/29/2002 Date Approved Designation Approved: Sponsor Contact Information Northwest Biotherapeutics, Inc. 22322 20th Avenue SE Suite 150 Bothell WA 98021 Generic Name: Autologous DNP-conjugated tumor vaccine Trade Name (if present): M-Vax Date Designated 2/23/1999 Date Approved Designation Approved: Sponsor Contact Information Avax Technologies, Inc. 9200 Indian Creek Parkway Building 9, Suite 200 Overland Park KS 66210 Generic Name: Autologous incubated macrophage Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/3/2004 Date Approved Proneuron Biotechnologies, Inc. 2029 Century Park East Sixth Floor Los Angeles CA 90067 Generic Name: Autologous olfactory neural progenitors Trade Name (if present): RhinoCytes Date Designated 2/1/2008 Date Approved Designation Approved: Sponsor Contact Information RhinoCyte, Inc. 201 E. Jefferson Street Louisville KY 40202-1246 Generic Name: Autologous or allogeneic limbal epithelial stem cells expanded ex vivo on human amniotic membrane Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/14/2005 Date Approved TissueTech, Inc. 7000 SW 97th Avenue Miami FL 33173 Generic Name: autologous tumor-derived gp96 heat shock protein-peptide complex Trade Name (if present): Oncophage Date Designated 5/10/2002 Date Approved Designation Approved: Sponsor Contact Information Antigenics, Inc. 3 Forbes Rd. Lexington MA 02421 Generic Name: autologous tumor-derived gp96 heat shock protein-peptide complex Trade Name (if present): Oncophage Date Designated 7/11/2002 Date Approved Designation Approved: Sponsor Contact Information Antigenics, Inc. 3 Forbes Rd. l MA 02421 Generic Name: Autolymphocyte therapy Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/12/1994 Date Approved Cytogen Corporation 600 College Road East CN 5308 Princeton NJ 08540-5308 Generic Name: aviptadil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/22/2005 Date Approved Biogen Idec MA, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: axitinib Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/31/2007 Date Approved Pfizer, Inc. La Jolla Laboratories San Diego CA 92121 Generic Name: azacitidine Trade Name (if present): Vidaza Date Designated 12/3/2001 Date Approved 5/19/2004 Designation Approved: Treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia and requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia Sponsor Contact Information Pharmion Corporation 2525 28th Street Boulder CO 80301 Generic Name: Azathioprine Trade Name (if present): Imuran Date Designated 9/14/1999 Date Approved Designation Approved: Sponsor Contact Information Oral Solutions, Inc. 787 Seventh Ave., 48th Floor New York NY 10019 Generic Name: aztreonam Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/12/2002 Date Approved Gilead Sciences (formerly Corus Pharma) 2025 First Ave. Suite 800 Seattle WA 98121 Generic Name: Bacillus Calmette-Guerin vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/9/2006 Date Approved OncoVac Corporation P. O. Box 970 Pacific Palisades CA 90272 Generic Name: Bacitracin Trade Name (if present): Altracin Date Designated 3/13/1984 Date Approved Designation Approved: Sponsor Contact Information A. L. Laboratories, Inc. One Executive Drive P.O. Box 1399 Fort Lee NJ 07024 Generic Name: Baclofen Trade Name (if present): Lioresal Intrathecal Date Designated 11/10/1987 Date Approved 6/25/1992 Designation Approved: Management of severe spasticity of spinal cord origin in patients who are unresponsive to oral baclofen therapy or experience intolerable CNS side effects at effective doses. Sponsor Contact Information Medtronic, Inc. 800 53rd Avenue N.E. Minneapolis MN 55432 Generic Name: Baclofen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/16/1991 Date Approved Infusaid, Inc. 1400 Providence Highway Norwood MA 02062 Generic Name: Baclofen Trade Name (if present): Lioresal Intrathecal Date Designated 9/26/1994 Date Approved Designation Approved: Sponsor Contact Information Medtronic, Inc. 800 53rd Avenue N.E. P.O. 1250 Minneapolis MN 55440-9087 Generic Name: baclofen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/2/2003 Date Approved Medtronic Neurological 710 Medtronic Parkway NE Minneapolis MN 55432-5604 Generic Name: Balsalazide disodium Trade Name (if present): Colazal Date Designated 8/12/2005 Date Approved 12/20/2006 Designation Approved: Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and Effectiveness of Colazal beyond 8 weeks in children (ages 5-17) and 12 weeks in adults have not been established. Sponsor Contact Information Salix Pharmaceuticals, Inc. 1700 Perimeter Park Drive Morrisville NC 27560 Generic Name: Basiliximab Trade Name (if present): Simulect Date Designated 12/12/1997 Date Approved 5/12/1998 Designation Approved: Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. Sponsor Contact Information Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover NJ 07936-1080 Generic Name: beclomethasone 17,21-dipropionate Trade Name (if present): Bec Date Designated 8/28/2001 Date Approved Designation Approved: Sponsor Contact Information Enteron Pharmaceuticals, Inc./DOR BioPharma, Inc. A Subsidiary of DOR BioPharma, Inc. 850 Bear Tavern Road Ewing NJ 08628 Generic Name: beclomethasone 17,21-diproprionate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2007 Date Approved DOR BioPharma, Inc. 850 Bear Tavern Road Suite 201 Ewing NJ 08628 Generic Name: Beclomethasone dipropionate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/27/1998 Date Approved Enteron Pharmaceuticals, Inc./DOR BioPharma, Inc. A Subsidiary of DOR BioPharma, Inc. 850 Bear Tavern Road Ewing NJ 08628 Generic Name: belatacept Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/20/2008 Date Approved Bristol-Myers Squibb Company P. O. Box 4000 Princeton NJ 08543-4000 Generic Name: Bendamustine hydrochloride Trade Name (if present): Treanda Date Designated 8/17/2007 Date Approved 3/20/2008 Designation Approved: Treatment of patients with chronic lymphocytic leukemia Sponsor Contact Information Cephalon, Inc. 41 Moores Road Frazer PA 19355 Generic Name: Benzoate and phenylacetate Trade Name (if present): Ucephan Date Designated 1/21/1986 Date Designated 1/21/1986 Date Approved Designation Approved: Sponsor Contact Information Immunex 2525 McGaw Avenue Immunex P.O. Box 19791 Irvine CA 92623 12/23/1987 Generic Name: benzoate/phenylacetate Trade Name (if present): Ammonul Date Designated 11/22/1993 Date Approved 2/17/2005 Designation Approved: Adjunctive therapy in the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. Sponsor Contact Information Medicis Pharmaceutical Corp. 8125 N. Hayden Road Scottsdale AZ 85258 Generic Name: Benzophenone-3, octylmethoxycinnamate, avobenzone, titanium dioxide, zinc oxide Trade Name (if present): Total Block VL SPF 75 Date Designated 8/13/2001 Date Approved Designation Approved: Sponsor Contact Information Fallien Cosmeceuticals Ltd. 677 W. Dekalb Pike King of Prussia PA 19406 Generic Name: Benzydamine hydrochloride Trade Name (if present): Tantum Date Designated 5/18/1998 Date Approved Designation Approved: Sponsor Contact Information Angelini Pharmaceuticals, Inc. 70 Grand Avenue River Edge NJ 07661 Generic Name: Benzylpenicillin, benzylpenicilloic, benzylpenilloic acid Trade Name (if present): Pre-Pen/MDM Date Designated 9/29/1987 Date Approved Designation Approved: Sponsor Contact Information AllerQuest LLC 836 Farmington Avenue Suite 207 West Hanford CT 06119-1551 Generic Name: Beractant Trade Name (if present): Survanta Intratracheal Suspension Date Designated 12/20/1993 Date Approved Designation Approved: Sponsor Contact Information Ross Laboratories 625 Cleveland Avenue Columbus OH 43215 Generic Name: Beractant Trade Name (if present): Survanta intratracheal suspension Date Designated 2/5/1986 Date Approved 7/1/1991 Designation Approved: Prevention of RDS (hyaline membrane disease) in premature infants less than 1250 grams birthweight or with evidence of surfactant deficiency. Sponsor Contact Information Ross Laboratories 625 Cleveland Avenue Columbus OH 43215 Generic Name: Beractant Trade Name (if present): Survanta intratracheal suspension Date Designated 2/5/1986 Date Approved 7/1/1991 Designation Approved: Treatment of ("rescue") of premature infants with RDS confirmed by x-ray and requiring mechanical ventilation. Sponsor Contact Information Ross Laboratories 625 Cleveland Avenue Columbus OH 43215 Generic Name: Beraprost Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/29/1999 Date Approved United Therapeutics Corporation 68 T.W. Alexander Drive, PO Box 14186 Research Triangle Park NC 27709 Generic Name: Beta alethine Trade Name (if present): Betathine Date Designated 3/24/1997 Date Approved Designation Approved: Sponsor Contact Information Dovetail Technologies, Inc. Bldg. 337, Paint Branch Drive College Park MD 20742 Generic Name: Beta alethine Trade Name (if present): Betathine Date Designated 3/24/1997 Date Approved Designation Approved: Sponsor Contact Information Dovetail Technologies, Inc. Bldg. 337, Paint Branch Drive College Park MD 20742 Generic Name: Betahistine dihydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/8/2007 Date Approved Floyd R. Sallee, M.D., Ph.D. University of Cincinnati School of Medicine ML 0559 Cincinnati OH 45267-0559 Generic Name: Betaine Trade Name (if present): Cystadane Date Designated 5/16/1994 Date Approved 10/25/1996 Designation Approved: Treatment of homocystinuria to decrease elevated homocysteine blood levels. Sponsor Contact Information Jazz Pharmaceuticals 3180 Porter Drive Palo Alto CA 94304 Generic Name: Bethanidine sulfate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/24/1989 Date Approved Medco Research, Inc. 8455 Beverly Blvd. Suite 308 Los Angeles CA 90048 Generic Name: Bethanidine sulfate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/20/1988 Date Approved Medco Research, Inc. 8455 Beverly Blvd. Suite 308 Los Angeles CA 90048 Generic Name: Betulinic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/9/2007 Date Approved Advanced Life Sciences, Inc. (ALS) 1440 Davey Road Woodridge IL 60517 Generic Name: Bevacizamub Trade Name (if present): Avastin Date Designated 5/26/2006 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: Bevacizumab Trade Name (if present): Avastin Date Designated 2/9/2006 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: Bevacizumab Trade Name (if present): Avastin Date Designated 10/20/2004 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way, MS #242 South San Francisco CA 94080-4990 Generic Name: Bevacizumab Trade Name (if present): Avastin Date Designated 11/6/2003 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: Bexarotene Trade Name (if present): Targretin Date Designated 6/18/1999 Date Approved 12/29/1999 Designation Approved: Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. Sponsor Contact Information Eisai Medical Research, Inc. 55 Challenger Road Ridgefield Park NJ 07660 Generic Name: bifidobacterium infantis 35624 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/24/2008 Date Approved Alimentary Health Limited Cork Airport Business Park, Building 2800 Cork IRELAND Generic Name: bifidobacterium longum infantis 35624 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/16/2003 Date Approved Alimentary Health Limited Guardwell, Kinsale County Cork IRELAND Generic Name: Bindarit Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/3/1998 Date Approved Angelini Pharmaceuticals, Inc. 70 Grand Avenue Suite 109 River Edge NJ 07661 Generic Name: Bioartificial liver system utilizing xenogenic hepatocytes in a hollow fiber bioreactor cartridge (BAL) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/11/2002 Date Approved Excorp Medical, Inc. Suite 235 7200 Hudson Blvd. Oakdale MN 55128 Generic Name: biocarbonate infusate Trade Name (if present): Normocarb HF Date Designated 8/9/2005 Date Approved 7/26/2006 Designation Approved: Use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace water and to correct electrolytes and acid-base imbalances in adults and children Sponsor Contact Information Dialysis Solutions, Inc. 14 Emmett Place Whitby, Ontario L1R 2B4 CANADA Generic Name: Bio-engineered oral mucosal tissue Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/27/2006 Date Approved TissueTech, Inc. 7000 SW 97th Avenue Miami FL 33173 Generic Name: Bis(4-fluorophenyl)phenylacetamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/2/2000 Date Approved ICAgen Inc. Ion Channel Advances PO Box 14487 Durham NC 27709 Generic Name: Bispecific molecule with two linked murine single-chain Fv regions directed against CD3 & CD19 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/6/2006 Date Approved MedImmune, LLC One MedImmune Way Gaithersburg MD 20878 Generic Name: bivalirudin Trade Name (if present): Angiomax Date Designated 11/2/2005 Date Approved Designation Approved: Sponsor Contact Information The Medicines Company 8 Campus Drive Parsippany NJ 07054 Generic Name: Bleomycin Trade Name (if present): Blenoxane Date Designated 2/9/1999 Date Approved Designation Approved: Sponsor Contact Information Genetronics, Inc. 11199 Sorrento Valley Rd. San Diego CA 92121-1334 Generic Name: Bleomycin sulfate Trade Name (if present): Blenoxane Date Designated 9/17/1993 Date Approved 2/20/1996 Designation Approved: Treatment of malignant pleural effusion. Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute P.O. Box 4000 Princeton NJ 08543 Generic Name: BMY-45622 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/15/1990 Date Approved Bristol-Myers Squibb 5 Research Parkway Wallingford CT 06492 Generic Name: Bortezomib Trade Name (if present): Velcade Date Designated 1/15/2003 Date Approved 3/25/2005 Designation Approved: Treatment of multiple myeloma patients who have received at least one prior therapy Sponsor Contact Information Millennium Pharmaceuticals, Inc. 40 Landsdowne Street Canbridge MA 02139 Generic Name: Bosentan Trade Name (if present): Tracleer Date Designated 10/6/2000 Date Approved 11/20/2001 Designation Approved: Treatment of pulmonary arterial hypertension. Sponsor Contact Information Actelion Life Sciences Ltd. 1840 Gateway Dr. 2nd Floor San Mateo CA 94404 Generic Name: Botulinum toxin type A Trade Name (if present): Dysport Date Designated 10/20/1999 Date Approved Designation Approved: Sponsor Contact Information Ipsen Limited 1 Bath Rd., Maidenhead Berkshire SL6 4UH UNITED KINGDOM Generic Name: Botulinum toxin type A Trade Name (if present): Dysport Date Designated 8/12/1998 Date Approved Designation Approved: Sponsor Contact Information Ipsen Limited 1 Bath Road Maidenhead Berkshire, SL6 4UH UNITED KINGDOM Generic Name: Botulinum toxin type A Trade Name (if present): Dysport Date Designated 3/23/1989 Date Approved Designation Approved: Sponsor Contact Information Porton International, Inc. 1155 15th Street, N.W., #315 Washington DC 20005 Generic Name: Botulinum toxin type A Trade Name (if present): Botox Date Designated 12/6/1991 Date Approved Designation Approved: Sponsor Contact Information Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine CA 92623-9534 Generic Name: Botulinum toxin type A Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/15/1992 Date Approved Botulinum Toxin Research Associates, Inc. 1261 Furnace Brook Parkway Quincy MA 02169 Generic Name: Botulinum toxin type A Trade Name (if present): Botox Date Designated 8/20/1986 Date Approved 12/21/2000 Designation Approved: Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia. Sponsor Contact Information Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine CA 92623-9534 Generic Name: Botulinum toxin type A Trade Name (if present): Botox Date Designated 3/22/1984 Date Approved 12/29/1989 Designation Approved: Sponsor Contact Information Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine CA 92713 Generic Name: Botulinum toxin type A Trade Name (if present): Botox Date Designated 3/22/1984 Date Approved 12/29/1989 Designation Approved: Sponsor Contact Information Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine CA 92713 Generic Name: Botulinum toxin type B Trade Name (if present): Myobloc Date Designated 1/16/1992 Date Approved 12/8/2000 Designation Approved: Treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. Sponsor Contact Information Elan Pharmaceuticals, Inc. 800 Gateway Blvd. South San Francisco CA 94080 Generic Name: Botulinum toxin type F Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/24/1991 Date Approved Ipsen Limited 27 Maple Street Milford MA 01757-3650 Generic Name: Botulinum toxin type F Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/5/1991 Date Approved Ipsen Limited (name changed from Porton International Inc) 27 Maple Street Milford MA 01757-3650 Generic Name: Botulism immune globulin Trade Name (if present): BabyBIG Date Designated 1/31/1989 Date Approved 10/23/2003 Designation Approved: Indicated for treatment of infant botulism caused by type A or type B Clostridium botulinum. Sponsor Contact Information California Department of Health Services 2151 Berkeley Way Berkeley CA 94704-1011 Generic Name: Bovine colostrum Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/19/1990 Date Approved Hastings, Donald DVM 1030 North Parkview Drive Bismarck ND 58501 Generic Name: Bovine immunoglobulin concentrate, Cryptosporidium parvum Trade Name (if present): Sporidin-G Date Designated 3/1/1994 Date Approved Designation Approved: Sponsor Contact Information GalaGen, Inc. 4001 Lexington Avenue North Arden Hills MN 55126 Generic Name: Bovine whey protein concentrate Trade Name (if present): Immuno-C Date Designated 9/30/1993 Date Approved Designation Approved: Sponsor Contact Information Biomune Systems, Inc. 540 Arapeen Drive, Suite 202 Salt Lake City UT 84108 Generic Name: Branched chain amino acids Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/23/1988 Date Approved Mount Sinai Medical Center One Gustave L. Levy Place New York NY 10029 Generic Name: Brimonidine Trade Name (if present): Alphagan Date Designated 2/7/2000 Date Approved Designation Approved: Sponsor Contact Information Allergan, Inc. 2525 Dupont Dr. P.O. Box 19534 Irvine CA 92623-9534 Generic Name: Brivaracetam Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/5/2005 Date Approved UCB Pharma, Inc. 1950 Lake Park Drive Smyra GA 30080 Generic Name: Brivudin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/15/2007 Date Approved SciClone Pharmaceuticals, Inc. 901 Mariner's Island Blvd. San Mateo CA 94404 Generic Name: Bromhexine Trade Name (if present): Bisolvon Date Designated 5/15/1989 Date Approved Designation Approved: Sponsor Contact Information Boehringer Ingelheim Pharmaceuticals, Inc. 900 Ridgebury Road, Box 368 Ridgefield CT 06877-0368 Generic Name: Broxuridine Trade Name (if present): Broxine/Neomark Date Designated 9/18/1995 Date Approved Designation Approved: Sponsor Contact Information NeoPharm, Inc. 225 East Deerpath, Suite 250 Lake Forest IL 60045 Generic Name: bryostatin-1 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/3/2001 Date Approved GPC Biotech, Inc. 610 Lincoln Street Waltham MA 02451 Generic Name: Buffered intrathecal electrolyte/dextrose injection Trade Name (if present): Elliotts B Solution Date Designated 8/24/1994 Date Approved 9/27/1996 Designation Approved: For the intrathecal administration of methotrexate and cytarabine for the prevention or treatment of meningeal leukemia and lymphocytic lymphoma. Sponsor Contact Information QOL Medical, LLC 12419 198th Drive, NE Woodinville WA 98072 Generic Name: Buffered Ursodeoxycholic Acid Trade Name (if present): Ursocarb Date Designated 9/3/2004 Date Approved Designation Approved: Sponsor Contact Information Digestive Care, Inc. 1120 Win Drive Bethlehem PA 18017 Generic Name: Buprenorphine hydrochloride Trade Name (if present): Subutex Date Designated 6/15/1994 Date Approved 10/8/2002 Designation Approved: Treatment of opioid dependence in patients 16 years of age or older Sponsor Contact Information Reckitt Benckiser Pharmaceuticals, Inc. 1901 Huguenot Road Richmond VA 23235 Generic Name: Buprenorphine in combination with naloxone Trade Name (if present): Suboxone Date Designated 10/27/1994 Date Approved 10/8/2002 Designation Approved: Treatment of opioid dependence in patients 16 years of age or older Sponsor Contact Information Reckitt Benckiser Pharmaceuticals, Inc. 1901 Huguenot Road Richmond VA 23235 Generic Name: Busulfan Trade Name (if present): Busulfex Date Designated 7/28/1994 Date Approved 2/4/1999 Designation Approved: For use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Sponsor Contact Information Otsuka Pharmaceutical Company Tokyo JAPAN Generic Name: Busulfan Trade Name (if present): Spartaject Date Designated 4/21/1994 Date Approved Designation Approved: Sponsor Contact Information Sparta Pharmaceuticals, Inc. 111 Rock Road Horsham PA 19044-2310 Generic Name: Busulfan Trade Name (if present): Spartajet-Busulfan Date Designated 3/5/2001 Date Approved Designation Approved: Sponsor Contact Information SuperGen, Inc. 4140 Dublin Boulevard Dublin CA 94568 Generic Name: busulfan Trade Name (if present): Partaject Date Designated 11/25/2002 Date Approved Designation Approved: Sponsor Contact Information SuperGen, Inc. 4140 Dublin Blvd Suite 200 Dublin CA 94568 Generic Name: Busulfan Trade Name (if present): Spartaject Date Designated 7/7/1997 Date Approved Designation Approved: Sponsor Contact Information SuperGen, Inc. Two Annabel Lane, Suite 220 San Ramon CA 94583 Generic Name: Buthionine sulfoxamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/5/2005 Date Approved USC-CHLA Institute for Pediatric Clinical Research Childrens Hospital of Los Angeles MS 55 Los Angeles CA 90027 Generic Name: Buthionine sulfoxamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/5/2005 Date Approved USC-CHLA Institute for Pediatric Clinical Research Childrens Hospital of Los Angeles 4650 Sunset Blvd, MS 55 Los Angeles CA 90027 Generic Name: Butyrylcholinesterase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/30/1992 Date Approved Shire Laboratories Inc. 1550 East Gude Drive Rockville MD 20850 Generic Name: Butyrylcholinesterase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/25/1992 Date Approved Shire Laboratories Inc. 1550 East Gude Drive Rockville MD 20850 Generic Name: BW 12C Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/23/1987 Date Approved Burroughs Wellcome Company 3030 Cornwallis Road P.O. Box 12700 Research Triangle Pk NC 27709 Generic Name: C1 esterase inhibitor (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/16/2004 Date Approved Lev Pharmaceuticals, Inc. 236 Old Lancaster Road Merion Station PA 19066 Generic Name: C1 esterase inhibitor (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/21/1996 Date Approved Alpha Therapeutic Corporation 5555 Valley Boulevard Los Angeles CA 90032 Generic Name: C1-esterase-inhibitor, human, pasteurized Trade Name (if present): Berinert P Date Designated 10/16/1992 Date Approved Designation Approved: Sponsor Contact Information CSL Behring L.L.C. 1020 First Ave. PO Box 61501 King of Prussia PA 19406-0901 Generic Name: C1-inhibitor Trade Name (if present): C1-inhibitor (human) vapor heated, Immuno Date Designated 8/30/1990 Date Approved Designation Approved: Sponsor Contact Information Baxter Healthcare Corp. One Baxter Way Westlake Village CA 91362 Generic Name: C1-inhibitor Trade Name (if present): C1-inhibitor (human) vapor heated, Immuno Date Designated 8/30/1990 Date Approved Designation Approved: Sponsor Contact Information Baxter Healthcare Corp. Hyland Division (Baxter Hyland) 550 North Brand Blvd. Glendale CA 91203 Generic Name: cAC10-vcMMAE (4) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/30/2007 Date Approved Seattle Genetics, Inc. 21823 30th Drive Southeast Bothell WA 98021 Generic Name: Caffeine Trade Name (if present): Cafcit Date Designated 9/20/1988 Date Approved 9/21/1999 Designation Approved: Short term treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age. Sponsor Contact Information O.P.R. Development, L.P. 1501 Wakarusa Drive Lawrence KS 66047 Generic Name: Calcitonin salmon nasal spray Trade Name (if present): Miacalcin Nasal Spray Date Designated 10/29/1990 Date Approved Designation Approved: Sponsor Contact Information Sandoz Pharmaceuticals Corp. 59 Route 10 East Hanover NJ 07936 Generic Name: Calcitonin-human for injection Trade Name (if present): Cibacalcin Date Designated 1/20/1987 Date Approved 10/31/1986 Designation Approved: Sponsor Contact Information Novartis Pharmaceutical Corporation 59 Route 10 East Hanover NJ 07936 Generic Name: Calcium acetate Trade Name (if present): Phos-Lo Date Designated 12/22/1988 Date Approved 12/10/1990 Designation Approved: Sponsor Contact Information Braintree Laboratories 60 Columbian Street P.O. Box 361 Braintree MA 02184 Generic Name: Calcium acetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/27/1989 Date Approved Pharmedic Company 28101 Ballard Road, Suite F Lake Forest IL 60045 Generic Name: Calcium carbonate Trade Name (if present): R & D calcium carbonate/600 Date Designated 6/6/1990 Date Approved Designation Approved: Sponsor Contact Information R & D Laboratories, Inc. 4204 Glencoe Avenue Marina Del Rey CA 90292 Generic Name: Calcium gluconate Trade Name (if present): Calgonate Date Designated 11/20/1997 Date Approved Designation Approved: Sponsor Contact Information Calgonate Corp. 190 Commerce Drive Warwick RI 02886 Generic Name: Calcium gluconate gel Trade Name (if present): H-F Gel Date Designated 5/21/1991 Date Approved Designation Approved: Sponsor Contact Information LTR Pharmaceuticals, Inc. 145 Sakonnet Blvd. Narragansett RI 02882 Generic Name: Calcium gluconate gel 2.5% Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/10/1990 Date Approved Paddock Laboratories, Inc. 3940 Quebec Avenue North Minneapolis MN 55427 Generic Name: Calfactant Trade Name (if present): Infasurf Date Designated 9/5/2000 Date Approved Designation Approved: Sponsor Contact Information Pneuma Partners, LLC 1576 Sweet Home Road Amherst NY 14228 Generic Name: Capsaicin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/2005 Date Approved TheraQuest Biosciences, LLC 146 Medinah Drive Blue Bell PA 19422-3212 Generic Name: Capsaicin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/29/2006 Date Approved Anesiva, Inc. 650 Gateway Blvd South San Francisco CA 94080 Generic Name: capsaicin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/23/2002 Date Approved NeurogesX, Inc. 981F Industrial Road San Carlos CA 94070 Generic Name: Capsaicin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/2/2003 Date Approved NeurogesX, Inc. San Carlos Business Park 981F Industrial Road San Carols CA 94070-4117 Generic Name: Carbamylglutamic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/20/1998 Date Approved Orphan Europe Immeuble "Le Guillaumet" 60, avenue du General de Gaulle FRANCE Generic Name: Carbovir Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/13/1989 Date Approved Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: carfilzomib Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/18/2008 Date Approved Proteolix, Inc. 333 Allerton Avenue South San Francisco CA 94080 Generic Name: Carmustine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/3/2000 Date Approved Direct Therapeutics, Inc. 460 Seaport Court Suite 220 Redwood CA 94063 Generic Name: Cascara sagrada fluid extract Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/21/1989 Date Approved Intramed Corporation 102 Tremont Way Augusta GA 30907 Generic Name: Catumaxomab Trade Name (if present): Removab Date Designated 6/9/2006 Date Approved Designation Approved: Sponsor Contact Information Fresenius Biotech North America, Inc. 99 Hayden Avenue Lexington MA 02420-9192 Generic Name: CD4 human truncated 369 AA polypeptide Trade Name (if present): Soluble T4 Date Designated 11/21/1989 Date Approved Designation Approved: Sponsor Contact Information SmithKline Beecham Route 23 & Woodmont Ave., P.O. Box 1510 King Of Prussia PA 19406 Generic Name: CD5-T lymphocyte immunotoxin Trade Name (if present): Xomazyme-H65 Date Designated 8/27/1987 Date Approved Designation Approved: Sponsor Contact Information Xoma Corporation 2910 Seventh Street Berkeley CA 94710 Generic Name: CDP571 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/11/1997 Date Approved Celltech Chiroscience Limited 216 Bath Road Slough SL1 4EN UNITED KINGDOM Generic Name: CDX-110 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/19/2007 Date Approved Celldex Therapeutics, inc. 222 Cameron Drive Phillipsburg NJ 08865 Generic Name: Ceftriaxone sodium Trade Name (if present): Rocephin Date Designated 3/28/2006 Date Approved Designation Approved: Sponsor Contact Information Mass General Hospital Merit E. Cudkowicz, MD, MSc Building 149 13th Street, Room 2274 Charlestown MA 02129 Generic Name: Cells produced using the AastromReplicelle System and SC-I Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/10/2002 Date Approved Aastrom Biosciences Incorporated P.O. Box 376 Ann Arbor MI 48106 Generic Name: Cenersen Trade Name (if present): Aezea Date Designated 2/27/2008 Date Approved Designation Approved: Sponsor Contact Information Eleos, Inc. One Valmont Plaza - Corporate Headquarters Omaha NE 68154 Generic Name: cenersen sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/8/2006 Date Approved ELEOS, Inc. 7824 Jackson Street Omaha NE 68114 Generic Name: Centruroides immune F(ab)2 Trade Name (if present): Alacramyn Date Designated 6/12/2000 Date Approved Designation Approved: Sponsor Contact Information Silanes Laboratories S.A. de C.V. Amores #1034 Col Del Valle C.P. 03100 Mexico D.F. MEXICO Generic Name: Ceramide trihexosidase/alphagalactosidase A Trade Name (if present): Fabrazyme Date Designated 1/19/1988 Date Approved 4/24/2003 Designation Approved: For use in patients with Fabry disease to reduce globotriaosylceramide (GL3) deposition in capillary endothelium of the kidney and certain other cell types Sponsor Contact Information Genzyme Corporation One Kendall Square Cambridge MA 02139-1562 Generic Name: cethromycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/28/2007 Date Approved Advanced LIfe Sciences, Inc. 1440 Davey Road Woodridge IL 60517 Generic Name: Cetiedil citrate injection Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/22/1988 Date Approved Baker Cummins Pharmaceuticals, Inc. Generic Name: cetuximab Trade Name (if present): Erbitux Date Designated 6/15/2007 Date Approved Designation Approved: Sponsor Contact Information ImClone Systems Incorporated 33 ImClone Drive Branchburg NJ 08876 Generic Name: Cetuximab Trade Name (if present): Erbitux Date Designated 7/3/2000 Date Approved 3/1/2006 Designation Approved: For use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and for use as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has Sponsor Contact Information ImClone Systems Incorporated 33 ImClone Drive Branchburg NJ 08876 Generic Name: Chenodeoxycholic acid Trade Name (if present): Chenofalk Date Designated 1/29/2004 Date Approved Designation Approved: Sponsor Contact Information Dr. Falk Pharma GmbH Leinenweberstrasse 5 9041 Freiburg, GERMANY GERMANY Generic Name: chenodeoxycholic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/12/2007 Date Approved Sigma Tau 800 South Frederik Avenue, Suite 300 Gaithersburg MD 20877 Generic Name: Chenodiol Trade Name (if present): Chenix Date Designated 9/21/1984 Date Approved 7/28/1983 Designation Approved: Sponsor Contact Information Solvay 901 Sawyer Road Marietta GA 30062 Generic Name: Chimeric (human-murine) G250 IgG monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/24/2000 Date Approved Wilex Biotechnology GmbH Grillparzerstrasse 10B 81675 Munich GERMANY Generic Name: chimeric (murine-human) IgG1 mAb against IL-6 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/2005 Date Approved Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: Chimeric (murine-human) IgG1k monoclonal antibody against interleukin-6 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/26/2006 Date Approved Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: Chimeric monoclonal antibodies Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/4/2005 Date Approved Thallion Pharmaceuticals, Inc. 7150 Alexander-Fleming Montreal, Quebec, H4S 2C8 CANADA Generic Name: Chimeric monoclonal antibody to mesothelin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/31/2006 Date Approved Morphotek, Inc. 210 Welsh Pool Road Exton PA 19341 Generic Name: Chimeric M-T412 (human-murine) IgG monoclonal anti-CD4 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/5/1991 Date Approved Centocor, Inc. 244 Great Valley Parkway Malvern PA 19355 Generic Name: Chimeric, humanized monoclonal antibody to staphylococcus Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/2000 Date Approved Biosynexus, Inc. 9298 Gaither Road Rockville MD 20877 Generic Name: Chlorhexidine gluconate mouthrinse Trade Name (if present): Peridex Date Designated 8/18/1986 Date Approved Designation Approved: Sponsor Contact Information Procter & Gamble Company Sharon Wood Technical Center 11370 Reed Hartman Highway Cincinnati OH 45241 Generic Name: Chlorotoxin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2007 Date Approved TransMolecular, Inc. 840 Memorial Drive Cambridge MA 02139 Generic Name: cholic acid (3 alpha, 7 alpha, 12 alpha trihydroxy 5-beta cholanolic acid) Trade Name (if present): Falkochol Date Designated 7/18/2003 Date Approved Designation Approved: Sponsor Contact Information Dr. Falk Pharma GmbH Leinenweberstrasse 5 Postfach 6529 GERMANY Generic Name: Choline chloride Trade Name (if present): IntraChol Date Designated 7/20/2006 Date Approved Designation Approved: Sponsor Contact Information Alan L. Buchman, M.D., M.S.P.H. Feinberg School of Medicine, Dept. of Gastroentero 676 N. St. Clair St., Suite 1400 Chicago IL 60611 Generic Name: Choline chloride Trade Name (if present): Intrachol Date Designated 2/10/1994 Date Approved Designation Approved: Sponsor Contact Information Bioniche Pharma USA LLC 272 E. Deerpath Road Suite 304 Lake Forest IL 60045 Generic Name: Chondrocyte-alginate gel suspension Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/1/1997 Date Approved Curis, Inc. 61 Moulton Street Cambridge MA 02138 Generic Name: Chondroitinase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/9/1995 Date Approved Bausch & Lomb Pharmaceuticals, Inc. 8500 Hidden River Pkwy. Tampa FL 33637 Generic Name: cilengitide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/27/2005 Date Approved EMD Serono, Inc. One Technology Place Rockland MA 02370 Generic Name: Ciliary neurotrophic factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/30/1992 Date Approved Regeneron Pharmaceuticals Inc 777 Old Saw Mill River Road Tarrytown NY 10591 Generic Name: Ciliary neurotrophic factor, recombinant human Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/8/1992 Date Approved Syntex-Synergen Neuroscience 3200 Walnut Street Boulder CO 80301 Generic Name: Ciliary neurotrophic factor, recombinant human Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/2/1992 Date Approved Syntex-Synergen Neuroscience 3200 Walnut Street Boulder CO 80301 Generic Name: cinacalcet Trade Name (if present): Sensipar Date Designated 5/12/2003 Date Approved 3/8/2004 Designation Approved: Treatment of hypercalcemia in patients with parathyroid carcinoma Sponsor Contact Information Amgen, Inc. One Amgen Center Drive Thousand Oaks CA 91320-1799 Generic Name: Cisplatin in liposomal formulation Trade Name (if present): SLIT Cisplatin for inhalation Date Designated 3/20/2007 Date Approved Designation Approved: Sponsor Contact Information Transave, Inc. 11 Deer Park Drive Monmouth Junction NJ 08852-1923 Generic Name: Cisplatin/epinephrine Trade Name (if present): IntraDose Date Designated 9/7/2000 Date Approved Designation Approved: Sponsor Contact Information Matrix Pharmaceutical, Inc. 34700 Campus Drive Fremont CA 94555-3612 Generic Name: Cisplatin/epinephrine Trade Name (if present): IntraDose Date Designated 4/3/2000 Date Approved Designation Approved: Sponsor Contact Information Matrix Pharmaceutical, Inc. 34700 Campus Drive Fremont CA 94555-3612 Generic Name: Citric acid, glucono-delta-lactone and magnesium carbonate Trade Name (if present): Renacidin Irrigation Date Designated 8/28/1989 Date Approved 10/2/1990 Designation Approved: Sponsor Contact Information United-Guardian, Inc. P.O. Box 2500 Smithtown NY 11787 Generic Name: Civamide Trade Name (if present): Zucapsaicin Date Designated 12/9/2002 Date Approved Designation Approved: Sponsor Contact Information Winston Laboratories, Inc. 100 Fairway Drive, Suite 134 Vernon Hills IL 60061 Generic Name: Cladribine Trade Name (if present): Leustatin Date Designated 7/20/1990 Date Approved Designation Approved: Sponsor Contact Information Johnson & Johnson Pharmaceutical Research & Dev., LLC 920 US Highway 202 P.O. Box 300 Raritan NJ 08869 Generic Name: Cladribine Trade Name (if present): Leustatin Injection Date Designated 11/15/1990 Date Approved 2/26/1993 Designation Approved: Sponsor Contact Information R. W. Johnson Pharmaceutical Research Institute Route 202, P.O. Box 300 Raritan NJ 08869 Generic Name: Cladribine Trade Name (if present): Leustatin Injection Date Designated 12/31/1990 Date Approved Designation Approved: Sponsor Contact Information R. W. Johnson Pharmaceutical Research Institute 1125 Tenton-Harbourton Road P. O. Box 200 Titusville NJ 08560 Generic Name: Cladribine Trade Name (if present): Mylinax Date Designated 4/19/1994 Date Approved Designation Approved: Sponsor Contact Information Johnson & Johnson Pharmaceutical R & D, LLC 920 Route 202 PO Box 300 Raritan NJ 08869-0602 Generic Name: Cladribine Trade Name (if present): Leustatin Injection Date Designated 4/19/1993 Date Approved Designation Approved: Sponsor Contact Information Johnson &Johnson Pharmaceutical Research Institute Route 202 South, P.O. Box 300 Raritan NJ 08869-0602 Generic Name: Clazosentan Trade Name (if present): Erajet Date Designated 2/16/2006 Date Approved Designation Approved: Sponsor Contact Information Actelion Pharmaceuticals Ltd. Gewerbestrasse 16 SWITZERLAND Generic Name: Clindamycin Trade Name (if present): Cleocin Date Designated 10/28/1988 Date Approved Designation Approved: Sponsor Contact Information Pfizer Inc. 235 East 42nd Street 150-3-46 New York NY 10017 Generic Name: Clindamycin Trade Name (if present): Cleocin Date Designated 10/28/1988 Date Approved Designation Approved: Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Unit 0633-298-113 Kalamazoo MI 49001-0199 Generic Name: Clindamycin hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/9/2006 Date Approved Autoimmunity Research Foundation 3423 Hill Canyon Avenue Thousand Oaks CA 91360 Generic Name: clobazam Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2007 Date Approved Ovation Pharmaceuticals, Inc. Four Parkway North Deerfield IL 60015 Generic Name: clofarabine Trade Name (if present): Clofarex Date Designated 3/14/2002 Date Approved Designation Approved: Sponsor Contact Information Genzyme Corp (Ilex Products, Inc.) 4545 Horizon Hill Blvd. San Antonio TX 78229-2263 Generic Name: clofarabine Trade Name (if present): Clolar Date Designated 2/7/2002 Date Approved 12/28/2004 Designation Approved: Treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens Sponsor Contact Information Genzyme Corporation 4545 Horizon Hill Blvd. San Antonio TX 78229-2263 Generic Name: Clofazimine Trade Name (if present): Lamprene Date Designated 6/11/1984 Date Approved 12/15/1986 Designation Approved: Sponsor Contact Information Novartis Pharmaceutical Corporation 59 Route 10 East Hanover NJ 07936 Generic Name: Clonazepam Trade Name (if present): Klonopin Date Designated 8/4/1994 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Clonazepam Intranasal Spray Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/19/2007 Date Approved Jazz Pharmaceuticals, Inc. 3180 Porter Drive Palo Alto CA 94304 Generic Name: Clonidine Trade Name (if present): Duraclon Date Designated 1/24/1989 Date Approved 10/2/1996 Designation Approved: In combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Sponsor Contact Information Roxane Laboratories, Inc. PO Box 16532 Columbus OH 43216-6532 Generic Name: Clostridial collagenase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/23/1996 Date Approved Auxilium Pharmaceuticals, Inc. 40 Valley Stream Parkway Malvern PA 19335 Generic Name: Clotrimazole Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/14/2005 Date Approved Effective Pharmaceuticals, Inc. 150 Broadway Suite 1800 New York NY 10038 Generic Name: Clotrimazole Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/13/2006 Date Approved EnVivo Pharmaceuticals, Inc. 480 Arsenal Street Watertown MA 02472 Generic Name: Clotrimazole Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/24/1995 Date Approved Brugnara, Carlo M.D. The Children's Hospital 300 Longwood Avenue, Bader 760 Boston MA 02115 Generic Name: c-myb antisense oligodeoxynucleotide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/22/2005 Date Approved Genta, Inc. Two Connell Drive Berkeley Heights NJ 07922 Generic Name: Coagulation factor IX Trade Name (if present): Mononine Date Designated 6/27/1989 Date Approved 8/20/1992 Designation Approved: Prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease. Sponsor Contact Information Armour Pharmaceutical Company 500 Arcola Road, P.O. Box 1200 Collegeville PA 19426 Generic Name: Coagulation Factor IX (human) Trade Name (if present): AlphaNine Date Designated 7/5/1990 Date Approved 12/31/1990 Designation Approved: Sponsor Contact Information Alpha Therapeutic Corporation 5555 Valley Boulevard Los Angeles CA 90032 Generic Name: Coagulation Factor IX (recombinant) Trade Name (if present): BeneFix Date Designated 10/3/1994 Date Approved 2/11/1997 Designation Approved: For the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency and Christmas disease), including control and prevention of bleeding in surgical settings. Sponsor Contact Information Genetics Institute, Inc. 87 Cambridge Park Drive Cambridge MA 02140 Generic Name: Coagulation factor VIIa (recombinant) Trade Name (if present): NovoSeven Date Designated 7/21/2004 Date Approved 10/13/2006 Designation Approved: Prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia Sponsor Contact Information Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: Coagulation factor VIIa (recombinant) Trade Name (if present): NovoSeven Date Designated 6/18/2004 Date Approved Designation Approved: Sponsor Contact Information Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: Coagulation factor VIIa (recombinant) Trade Name (if present): NovoSeven Date Designated 9/10/2004 Date Approved 7/11/2005 Designation Approved: Prevention of bleeding in surgical interventions or invasive procedures in patients with congenital F VII deficiency Sponsor Contact Information Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: Coagulation Factor VIIa (Recombinant) Trade Name (if present): NovoSeven Date Designated 7/16/2004 Date Approved 10/13/2006 Designation Approved: Treatment of bleeding episodes in surgical interventions or invasive procedures in patients with acquired hemophilia Sponsor Contact Information Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: Coagulation factor VIIa (recombinant) Trade Name (if present): NovoSeven Date Designated 6/18/2004 Date Approved 8/12/2005 Designation Approved: Prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX Sponsor Contact Information Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: Coagulation factor VIIa (Recombinant) Trade Name (if present): NovoSeven Date Designated 6/18/2004 Date Approved Designation Approved: Sponsor Contact Information Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: Coagulation factor VIIa (recombinant) Trade Name (if present): NovoSeven Date Designated 9/10/2004 Date Approved 7/11/2005 Designation Approved: Treatment of bleeding episodes in patients with Factor VII Deficiency Sponsor Contact Information Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: Coagulation Factor VIIa (Recombinant) Trade Name (if present): NovoSeven Date Designated 10/3/2006 Date Approved Designation Approved: Sponsor Contact Information Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: Coagulation factor VIIa (recombinant) Trade Name (if present): NovoSeven Date Designated 6/6/1988 Date Approved 3/25/1999 Designation Approved: Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX. Sponsor Contact Information Novo Nordisk, Inc. 100 Overlook Center Suite 200 Princeton NJ 08540-7810 Generic Name: cobiprostone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/14/2002 Date Approved Sucampo Pharmaceuticals, Inc. 4520 East-West Highway Third Floor Bethesda MD 20814 Generic Name: coccidioidin SD Skin Test Antigen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/19/2007 Date Approved Allermed Labortories, Inc. 7203 Convoy Court San Diego CA 92111 Generic Name: Coenzyme Q10 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/5/2001 Date Approved Integrative Therapeutics, Inc. 825 Challenger Drive Green Bay WI 54311 Generic Name: Colchicine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/25/2007 Date Approved AR Scientific, Inc. 1100 Orthodox Street Philadelphia PA 19124 Generic Name: Colchicine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/25/2007 Date Approved AR Scientific, Inc. 1100 Orthodox Street Philadelphia PA 19124 Generic Name: Colchicine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/9/1985 Date Approved Pharmacontrol Corporation 661 Palisade Ave., P.O. Box 931 Englewood Cliffs NJ 07632 Generic Name: Colfosceril palmitate, cetyl alcohol, tyloxapol Trade Name (if present): Exosurf Neonatal for Intratracheal Suspension Date Designated 10/20/1989 Date Approved 8/2/1990 Designation Approved: Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Colfosceril palmitate, cetyl alcohol, tyloxapol Trade Name (if present): Exosurf Neonatal for Intratracheal Suspension Date Designated 10/20/1989 Date Approved 8/2/1990 Designation Approved: Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Colfosceril palmitate, cetyl alcohol, tyloxapol Trade Name (if present): Exosurf Date Designated 1/11/1993 Date Approved Designation Approved: Sponsor Contact Information GlaxoSmithKline 5 Moore Drive P.O. Box 13398 Research Triangle Park NC 27709 Generic Name: Collagenase (lyophilized) for injection Trade Name (if present): Plaquase Date Designated 3/12/1996 Date Approved Designation Approved: Sponsor Contact Information Auxilium Pharmaceuticals, Inc. 40 Valley Stream Parkway Malvern PA 19355 Generic Name: Combretastatin A4 phosphate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/8/2006 Date Approved OXiGENE, Inc. 230 Third Avenue Waltham MA 02451 Generic Name: Combretastatin A4 Phosphate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/23/2003 Date Approved OXiGENE, Inc 321 Arsenal Street Watertown MA 02472 Generic Name: conjugate of human transferrin and a mutant diphtheria toxin (CRM 107) Trade Name (if present): TransMID Date Designated 12/3/2001 Date Approved Designation Approved: Sponsor Contact Information Xenova Biomedix Limited 957 Budkingham Avenue Slough UNITED KINGDOM Generic Name: conjugated bile acids Trade Name (if present): COBARTin Date Designated 7/18/2003 Date Approved Designation Approved: Sponsor Contact Information Jarrow Formulas, Inc. 1824 S. Robertson Blvd. Los Angeles CA 90035-4317 Generic Name: Contulakin-G Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/7/2005 Date Approved Cognetix, Inc. 421 Wakara Way Salt Lake City UT 84108 Generic Name: Cordycepin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/5/2007 Date Approved OncoVista, Inc. 14785 Omicron Drive San Antonio TX 78245 Generic Name: Corticorelin ovine triflutate Trade Name (if present): Acthrel Date Designated 11/24/1989 Date Approved 5/23/1996 Designation Approved: To differentiate between pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome. Sponsor Contact Information Ferring Laboratories, Inc. 400 Rella Boulevard, Suite 201 Suffern NY 10901 Generic Name: Corticotropin-releasing factor, human Trade Name (if present): Xerecept Date Designated 4/6/1998 Date Approved Designation Approved: Sponsor Contact Information Neurobiological Technologies, Inc. 1387 Marina Way South Richmond CA 94804 Generic Name: Coumarin Trade Name (if present): Onkolox Date Designated 12/22/1994 Date Approved Designation Approved: Sponsor Contact Information Drossapharm LTD 4002 Basel SWITZERLAND Generic Name: Coxsackievirus A21 Trade Name (if present): Cavatak Date Designated 12/15/2005 Date Approved Designation Approved: Sponsor Contact Information Viralytics Limited P. O. Box 1045 Pymble Business Centre AUSTRALIA Generic Name: Creatine Trade Name (if present): Creapure Date Designated 10/11/2005 Date Approved Designation Approved: Sponsor Contact Information Avicena Group, Inc. 228 Hamilton Avenue Palo Alto CA 94301 Generic Name: creatine Trade Name (if present): Creapure Date Designated 2/12/2002 Date Approved Designation Approved: Sponsor Contact Information Avicena Group, Inc. 580 California St. Suite 1600 San Francisco CA 94104 Generic Name: Cromolyn sodium Trade Name (if present): Gastrocrom Date Designated 3/8/1984 Date Approved 12/22/1989 Designation Approved: Sponsor Contact Information Fisons Corporation 755 Jefferson Rd P.O. Box 1710 Rochester NY 14603 Generic Name: Cromolyn sodium 4% ophthalmic solution Trade Name (if present): Opticrom 4% ophthalmic solution Date Designated 7/24/1985 Date Approved 10/3/1984 Designation Approved: Sponsor Contact Information Fisons Corporation 755 Jefferson Rd. P.O. Box 1710 Rochester NY 14603 Generic Name: Cryptosporidium hyperimmune bovine colostrum IgG concentrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/30/1991 Date Approved ImmuCell Corporation 56 Evergreen Drive Portland ME 04103 Generic Name: cultured, partially T-Cell depleted, allogenic thymic tissue for transplantation Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/15/2003 Date Approved Duke University Medical Center Division of Pediatric Allergy & Immunology Erwin Road Durham NC 27710 Generic Name: CY-1503 Trade Name (if present): Cylexin Date Designated 7/18/1997 Date Approved Designation Approved: Sponsor Contact Information Cytel Corporation 3525 John Hopkins Court San Diego CA 92121 Generic Name: CY-1503 Trade Name (if present): Cylexin Date Designated 12/22/1993 Date Approved Designation Approved: Sponsor Contact Information Cytel Corporation 3525 John Hopkins Court San Diego CA 92121 Generic Name: CY-1899 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/16/1994 Date Approved Cytel Corporation 3525 John Hopkins Court San Diego CA 92121 Generic Name: Cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl2-(methylamino)nona-6,8-dienoyl}-L-2aminobytyrl-N-methyl-glycyl-N-methyl-Lleucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-Dalanyl-N-methyl-L-leucyl-N-methyl-L-leucylN-methyl-L-valyl} Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/20/2006 Date Approved Lux Biosciences, Inc. Hoarborside Financial Center Plaza 10, 14th Floor Jersey City NJ 07302 Generic Name: Cyclosporin A Trade Name (if present): Mitogard Date Designated 10/29/2004 Date Approved Designation Approved: Sponsor Contact Information Maas Biolab,LLC Tecnology Ventures Corporation Technopolis 1155 University Blvd., SE Albuquerque NM 87106 Generic Name: Cyclosporine Trade Name (if present): Designation Approved: Kristin Miller, CSO, HFD-590. Sponsor Contact Information Date Designated 11/25/2003 Date Approved APT Pharmaceuticals, Inc. 950 Tower Lane Suite 790 Foster City CA 94404 Generic Name: Cyclosporine Trade Name (if present): Pluminiq Date Designated 11/25/2003 Date Approved Designation Approved: Sponsor Contact Information APT Pharmaceuticals, Inc. 950 Tower Lane Suite 790 Foster City CA 94404 Generic Name: Cyclosporine 2% ophthalmic ointment Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/1/1991 Date Approved Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine CA 92623-9534 Generic Name: Cyclosporine 2% ophthalmic ointment Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/1/1991 Date Approved Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine CA 92623-9534 Generic Name: Cyclosporine A Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/4/2007 Date Approved NOVAGALI Pharma SA Batiment Genavenir IV F-91058-Evry cedex FRANCE Generic Name: cyclosporine A Trade Name (if present): NOVA22007 Date Designated 4/9/2008 Date Approved Designation Approved: Sponsor Contact Information Novagali Pharma S.A. 1 rue Pierre Fontaine 91058 Evry cedex FRANCE Generic Name: Cyclosporine A implant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/8/2007 Date Approved Lux Biosciences, Inc. Harborside Financial Center Plaza 10, 14th Floor Jersey City NJ 07302 Generic Name: Cyclosporine in combination with omega-3 polyunsaturated fatty acids Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/6/2000 Date Approved RTP Pharma Corporation 200 Westpark Corporate Center 4364 South Alston Avenue Durham NC 27713-2280 Generic Name: Cyclosporine ophthalmic Trade Name (if present): Optimmune Date Designated 11/9/1988 Date Approved Designation Approved: Sponsor Contact Information University Of Georgia College Of Veterinary Medicine Department of Small Animal Medicine Athens GA 30602 Generic Name: Cyproterone acetate Trade Name (if present): Androcur Date Designated 10/26/1984 Date Approved Designation Approved: Sponsor Contact Information Berlex Laboratories, Inc. 300 Fairfield Road Wayne NJ 07470 Generic Name: Cys-His-Ala-Val-Cys Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/14/2008 Date Approved Adherex Technologies, Inc. 4620 Creekstone Drive Durham NC 27703 Generic Name: Cysteamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/1/1986 Date Approved Thoene, Jess G., M.D. University of Michigan Medical School 300 NIB, 1192 SE Ann Arbor MI 48109-0408 Generic Name: Cysteamine Trade Name (if present): Cystagon Date Designated 1/25/1991 Date Approved 8/15/1994 Designation Approved: Treatment of nephropathic cystinosis in adults and children. Sponsor Contact Information Mylan Laboratories, Inc. 781 Chestnut Ridge Road P.O. Box 4310 Morgantown WV 26504 Generic Name: Cysteamine hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/19/1997 Date Approved Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Cystic fibrosis gene therapy Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/30/1992 Date Approved Genzyme Corporation One Mountain Rd. P.O. Box 9322 Framingham MA 01701-9322 Generic Name: Cystic fibrosis Tr gene therapy (recombinant adenovirus) Trade Name (if present): AdGVCFTR.10 Date Designated 3/9/1995 Date Approved Designation Approved: Sponsor Contact Information GenVec, Inc. 12111 Parklawn Drive Rockville MD 20852 Generic Name: Cystic fibrosis transmembrane conductance regulator Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/14/1992 Date Approved Genzyme Corporation One Mountain Road P.O. Box 9322 Framingham MA 01701-9322 Generic Name: Cystic fibrosis transmembrane conductance regulator gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/8/1993 Date Approved Genetic Therapy, Inc. 938 Clopper Road Gaithersburg MD 20878 Generic Name: Cytarabine liposomal Trade Name (if present): DepoCyt Date Designated 6/2/1993 Date Approved 4/1/1999 Designation Approved: Intrathecal treatment of lymphomatous meningitis. Sponsor Contact Information Pacira Pharmaceuticals, Inc. 10450 Science Center Drive San Diego CA 92121 Generic Name: cytarabine liposome Trade Name (if present): DepoCyt Date Designated 1/30/2007 Date Approved Designation Approved: Sponsor Contact Information Bruce Frankel, MD Medical University of South Carolina 96 Jonathan Lucas Street, Suite 428 CSB Charleston SC 29425 Generic Name: Cytomegalovirus DNA Vaccine w/Copolymer/Benzalkonium Chloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/23/2006 Date Approved Vical Inc. 10390 Pacific Center Court San Diego CA 92121 Generic Name: Cytomegalovirus DNA vaccine with plasmids expressing pp65 and gB genes Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/3/2005 Date Approved Vical Incorporated 10390 Pacific Center Court San Diego CA 92121 Generic Name: Cytomegalovirus immune globulin (human) Trade Name (if present): CytoGam Date Designated 8/3/1987 Date Approved 12/4/1998 Designation Approved: #1) Attenuation of primary CMV disease associated with kidney transplant recipients who are seronegative for CMV and who receive a kidney from a CMV seropositve donor; #2) Prophylaxis of CMV disease associated transplantation of kidney (all other), lung, liver, pancreas and heart. Sponsor Contact Information Massachussetts Public Health Biologic Laboratories 305 South Street Boston MA 02130-3597 Generic Name: Cytomegalovirus immune globulin intravenous (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/28/1991 Date Approved Bayer Corporation Pharmaceutical Division, Biological Products 400 Morgan Lane New Haven CT 06516 Generic Name: Daclizumab Trade Name (if present): Zenapax Date Designated 3/5/1993 Date Approved 12/10/1997 Designation Approved: Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Dantrolene sodium Trade Name (if present): Dantrium Date Designated 12/14/1987 Date Approved Designation Approved: Sponsor Contact Information Norwich Eaton Pharmaceuticals P.O. Box 191 Norwich NY 13815 Generic Name: Dapsone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/7/1994 Date Approved Jacobus Pharmaceutical Company, Inc. 37 Cleveland Lane P.O. Box 5290 Princeton NJ 08540 Generic Name: Dapsone USP Trade Name (if present): Dapsone Date Designated 1/8/1992 Date Approved Designation Approved: Sponsor Contact Information Jacobus Pharmaceutical Company 37 Cleveland Lane P.O. Box 5290 Princeton NJ 08540 Generic Name: Dapsone USP Trade Name (if present): Dapsone Date Designated 12/24/1991 Date Approved Designation Approved: Sponsor Contact Information Jacobus Pharmaceutical Company 37 Cleveland Lane P.O. Box 5290 Princeton NJ 08540 Generic Name: Dasatinib Trade Name (if present): Sprycel Date Designated 11/18/2005 Date Approved 6/28/2006 Designation Approved: Treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy Sponsor Contact Information Bristol-Myers Squibb Company 5 Research Parkway Wallingford CT 06492 Generic Name: Dasatinib Trade Name (if present): Sprycel Date Designated 11/28/2005 Date Approved 6/28/2006 Designation Approved: Treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib Sponsor Contact Information Bristol-Myers Squibb Company 5 Research Parkway Wallingford CT 06492 Generic Name: Daunorubicin citrate liposome injection Trade Name (if present): DaunoXome Date Designated 5/14/1993 Date Approved 4/8/1996 Designation Approved: First line cytotoxic therapy for advanced, HIV related Kaposi's sarcoma. Sponsor Contact Information NeXstar Pharmaceuticals, Inc. 650 Cliffside Drive San Dimas CA 91773 Generic Name: DEAE-rebeccamycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/1/2004 Date Approved Helsinn Healthcare SA Via Pian Scairolo, 6912 Pazzallo Lugano SWITZERLAND Generic Name: debrase Trade Name (if present): Debridase Date Designated 8/20/2003 Date Approved Designation Approved: Sponsor Contact Information MediWound, Ltd. 3, Azrieli Center Triangular Tower 45th Floor ISRAEL Generic Name: Decitabine Trade Name (if present): Dacogen Date Designated 8/4/2006 Date Approved Designation Approved: Sponsor Contact Information MGI Pharma 6611 Tributary Street Baltimore MD 21224-6515 Generic Name: decitabine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/9/2002 Date Approved MGI CP, d/b/a MGI Pharma 6611 Tributary Street Baltimore MD 21224 Generic Name: Decitabine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/8/1999 Date Approved MGI CP, Inc. d/b/a MGI Pharma 6611 Tributary Street Suite 200 Baltimore MD 21224 Generic Name: Decitabine Trade Name (if present): Designation Approved: for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all FrenchAmerican-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Dacogen Date Designated 3/8/1999 Date Approved 5/2/2006 Sponsor Contact Information MGI CP, Inc. d/b/a MGI Pharma 6611 Tributary Street Suite 200 Baltimore MD 21224 Generic Name: Deferasirox Trade Name (if present): Exjade Date Designated 11/21/2002 Date Approved 11/2/2005 Designation Approved: Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age or older Sponsor Contact Information Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover NJ 07936-1080 Generic Name: deferiprone Trade Name (if present): Ferriprox Date Designated 12/12/2001 Date Approved Designation Approved: Sponsor Contact Information ApoPharma, Inc. A Division of Apotex Research Inc. Toronto, Canada M9L 1T9 CANADA Generic Name: deferoxamine-starch conjugate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/28/2005 Date Approved Biomedical Frontiers, Inc. 1095 10th Avenue, SE Minneapolis MN 55414 Generic Name: defibrotide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/8/2007 Date Approved Gentium SpA Piazza XX Settembre, 2 ITALY Generic Name: Defibrotide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/21/2003 Date Approved Gentium SpA Piazza XX Settembre, 2 22079 Villa Guardia (CO) ITALY Generic Name: Defibrotide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/5/1985 Date Approved Crinos International Via Belvedere 1 Villa Guardia, Italy 22079 Generic Name: Dehydroepiandrosterone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/13/1994 Date Approved Genelabs Technologies, Inc. 505 Penobscot Drive Redwood City CA 94063 Generic Name: Dehydroepiandrosterone (DHEA) Trade Name (if present): Fidelin Date Designated 8/19/2003 Date Approved Designation Approved: Sponsor Contact Information Paladin Labs, Inc. 6111 Royalmount Avenue, Suite 102 Montreal Quebec H4P 2T4 CANADA Generic Name: Dehydroepiandrosterone sulfate sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/29/1997 Date Approved Pharmadigm, Inc. 2401 Foothill Drive Salt Lake City UT 84109-1405 Generic Name: Dehydroepiandrosterone sulfate sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/28/1997 Date Approved Pharmadigm, Inc. 2401 Foothill Drive Salt Lake City UT 84109-1405 Generic Name: denileukin diftitox Trade Name (if present): Ontak Date Designated 8/21/1996 Date Approved 2/5/1999 Designation Approved: Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor. Sponsor Contact Information Eisai Medical Research, Inc. 55 Challenger Road Ridgefield Park NJ 07660 Generic Name: Deslorelin Trade Name (if present): Somagard Date Designated 11/5/1987 Date Approved Designation Approved: Sponsor Contact Information Roberts Pharmaceutical Corp. Meridian Center II Four Industrial Way West Eatontown NJ 07724-2274 Generic Name: Desmoglein 3 synthetic peptide (PI-0824) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/26/2004 Date Approved Peptimmune, Inc. 64 Sidney Street Cambridge MA 02139-4170 Generic Name: Desmopressin acetate Trade Name (if present): Designation Approved: Treatment of patients with hemophilia A or von Willebrand's disease (type I) whose factor VIII coagulant activity level is greater than 5%. Sponsor Contact Information Date Designated 1/22/1991 Date Approved 3/7/1994 Aventis Behring L.L.C. 1020 First Avenue PO Box 61501 King of Prussia PA 19406-0901 Generic Name: Dexamethasone Trade Name (if present): Posurdex Date Designated 9/11/1998 Date Approved Designation Approved: Sponsor Contact Information Allergan 2525 Dupont Drive P. O. Box 19534 Irvine CA 92623-9534 Generic Name: dexanabinol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/11/2004 Date Approved Pharmos Corporation 99 Wood Avenue Suite 311 Iselin NJ 08830 Generic Name: dexrazoxane Trade Name (if present): Totect Date Designated 3/25/2004 Date Approved 9/6/2007 Designation Approved: Treatment of extravasation resulting from IV anthracycline chemotherapy Sponsor Contact Information Topo Target A/S Fruebjergvej 3, 2100 Copenhagen DENMARK Generic Name: Dexrazoxane Trade Name (if present): Zinecard Date Designated 12/17/1991 Date Approved 5/26/1995 Designation Approved: Cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative dose of 300mg/m2. Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Kalamazoo MI 49001-0199 Generic Name: dextran 1 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/21/2003 Date Approved BCY LifeSciences Inc. 160 Eglinton Ave. East Suite 600 Toronto, Ontario M4P 3B CANADA Generic Name: Dextran 70 Trade Name (if present): Dehydrex Date Designated 3/5/1990 Date Approved Designation Approved: Sponsor Contact Information Holles Laboratories, Inc. 30 Forest Notch Cohasset MA 02025 Generic Name: Dextran and deferoxamine Trade Name (if present): Bio-Rescue Date Designated 3/8/1991 Date Approved Designation Approved: Sponsor Contact Information Biomedical Frontiers, Inc. 1095 10th Avenue S.E. Minneapolis MN 55414 Generic Name: Dextran sulfate (inhaled, aerosolized) Trade Name (if present): Uendex Date Designated 10/5/1990 Date Approved Designation Approved: Sponsor Contact Information Kennedy & Hoidal, M.D.'s University Of Utah Medical Center 50 North Medical Drive, Room 4R240 Salt Lake City UT 84132 Generic Name: Dextran sulfate sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/19/1987 Date Approved Ueno Fine Chemicals Industry, Ltd. 2-31 Koraibashi, Higashi-ku Osaka 541 JAPAN Generic Name: DHA-paclitaxel Trade Name (if present): Taxoprexin Date Designated 9/25/2001 Date Approved Designation Approved: Sponsor Contact Information Luitpold Pharmaceuticals, Inc.. 1000 Madison Ave. Norristown PA 19403 Generic Name: DHA-paclitaxel Trade Name (if present): Taxoprexin Date Designated 5/1/2003 Date Approved Designation Approved: Sponsor Contact Information Luitpold Pharmaceuticals, Inc. 1000 Madison Ave. Norristown PA 19403 Generic Name: DHA-paclitaxel Trade Name (if present): Taxoprexin Date Designated 10/10/2002 Date Approved Designation Approved: Sponsor Contact Information Luitpold Pharmaceuticals, Inc.. 1000 Madison Ave. Norristown PA 19403 Generic Name: Dianeal peritoneal dialysis solution with 1.1% amino acids Trade Name (if present): Nutrineal (Peritoneal Dialysis Solution with 1.1% Amino Acid Date Designated 6/11/1992 Date Approved Designation Approved: Sponsor Contact Information Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park IL 60085 Generic Name: Diazepam viscous solution for rectal administration Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/25/1992 Date Approved 7/29/1997 Valeant Pharmaceuticals 3300 Hyland Avenue Costa Mesa CA 92626 Generic Name: Diaziquone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/10/1983 Date Approved Warner-Lambert Company 2800 Plymouth Rd., P.O. Box 1047 Ann Arbor MI 48106 Generic Name: Dideoxyinosine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/22/1988 Date Approved Bristol-Myers Squibb 2400 West Lloyd Expressway Evansville IN 47721 Generic Name: Diethyldithiocarbamate Trade Name (if present): Imuthiol Date Designated 4/3/1986 Date Approved Designation Approved: Sponsor Contact Information Connaught Laboratories Route 611, P.O. Box 187 Swiftwater PA 18370 Generic Name: diethylenetriaminepentaacetate (DPTA) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/14/2004 Date Approved CIS-US 10 DeAngelo Drive Bedford MA 01730 Generic Name: Diethylenetriaminepentaacetic acid (DTPA) Trade Name (if present): Designation Approved: Treatment of internal contamination with plutonium, americium or curium Sponsor Contact Information Date Designated 4/28/2004 Date Approved 8/11/2004 Hameln Pharmaceuticals gmbh Langes Feld 13 Hameln GERMANY Generic Name: Diethylnorspermine (DENSPM) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/25/2004 Date Approved Genzyme Corporation 153 Second Avenue Waltham MA 02451 Generic Name: diferuloylmethane Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/13/2003 Date Approved Allertein Therapeutics, LLC 640 Sasco Hill Road Fairfield CT 06824 Generic Name: Digitoxin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/27/2005 Date Approved Bette S. Pollard, LLC 11008 Lamplighter Lane Potomac MD 20854 Generic Name: digitoxin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/18/2001 Date Approved PrimeCyte, Inc. 130 Fifth Ave., N. Seattle WA 98109-4933 Generic Name: digitoxin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/2/2001 Date Approved PrimeCyte, Inc. 130 Fifth Ave., N. Seattle WA 98109-4933 Generic Name: Digoxin immune FAB (Ovine) Trade Name (if present): Digibind Date Designated 11/1/1984 Date Approved 4/22/1986 Designation Approved: Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Digoxin immune fab(ovine) Trade Name (if present): Digidote Date Designated 3/11/1985 Date Approved Designation Approved: Sponsor Contact Information Boehringer Mannheim Corp. 1301 Piccard Drive Rockville MD 20850 Generic Name: dihydroartemisinin and piperaquine Trade Name (if present): Eurartesim Date Designated 1/8/2007 Date Approved Designation Approved: Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Dihydrotestosterone Trade Name (if present): Androgel -DHT Date Designated 2/5/1996 Date Approved Designation Approved: Sponsor Contact Information Besins Internaitonal, US Inc. 610 Herndon Parkway Suite 750 Herndon VA 20170 Generic Name: Dimethyl sulfoxide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/22/1994 Date Approved Abela Pharmaceuticals, Inc. 21581 Midcrest Drive Lake Forest CA 92630 Generic Name: Dimethyl sulfoxide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/6/1986 Date Approved Research Industries Corp. Generic Name: Dimethylsulfoxide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/6/1998 Date Approved Cancer Technologies, Inc. 7301 East 22nd Street Suite 10E Tucson AZ 85710 Generic Name: Dimethylsulfoxide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/15/1997 Date Approved Cancer Technologies, Inc. 7301 East 22nd Street Suite 10E Tucson AZ 85710 Generic Name: Dipalmitoylphosphatidylcholine /phosphatidylglycerol Trade Name (if present): ALEC Date Designated 7/28/1988 Date Approved Designation Approved: Sponsor Contact Information Forum Products, Inc. 33 Flying Point Road Southampton NY 11968 Generic Name: diphenylcyclopenone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/13/2003 Date Approved Lloyd E. King, Jr. 1900 Patterson Street Suite 104 Nashville TN 37203 Generic Name: Disaccharide tripeptide glycerol dipalmitoyl Trade Name (if present): Immther Date Designated 3/1/1990 Date Approved Designation Approved: Sponsor Contact Information ImmunoTherapeutics, Inc. 3505 Riverview Circle Moorhead MN 56560 Generic Name: Disodium clodronate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/16/1993 Date Approved Discovery Experimental & Development, Inc. 29949 S.R. 54 West Wesley Chapel FL 33543 Generic Name: Disodium clodronate tetrahydrate Trade Name (if present): Bonefos Date Designated 3/5/1990 Date Approved Designation Approved: Sponsor Contact Information Anthra Pharmaceuticals, Inc. 103 Carnegie Center, Suite 102 Princeton NJ 08540 Generic Name: Disodium silibinin dihemisuccinate Trade Name (if present): Legalon Date Designated 7/10/1986 Date Approved Designation Approved: Sponsor Contact Information Pharmaquest Corporation 4470 Redwood Highway San Rafael CA 94903 Generic Name: DMP 777 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/4/1996 Date Approved DuPont Pharmaceuticals Company Chestnut Run, Maple Run Centre Rd. Wilmington DE 19805 Generic Name: DNA plasmid vector expressing human IL12 gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/4/2005 Date Approved Expression Genetics, Inc. 2215 Mock Road Huntsville AL 35801 Generic Name: DNA-lipid complex (DMRIE/DOPE)/plasmid vector (VCL-1102, Vical) expressing human interleukin-2 Trade Name (if present): Leuvectin Date Designated 4/28/2000 Date Approved Designation Approved: Sponsor Contact Information Vical Incorporated 9373 Towne Center Dr. Suite 100 San Diego CA 92121-3088 Generic Name: DNP-Modified autologous tumor vaccine Trade Name (if present): O-Vax Date Designated 9/21/2000 Date Approved Designation Approved: Sponsor Contact Information AVAX Technologies, Inc. 9200 Indian Creek Parkway Building 9, Suite 200 Overland Park KS 66210 Generic Name: docosahexanoic acid-paclitaxel Trade Name (if present): Taxoprexin Date Designated 3/5/2001 Date Approved Designation Approved: Sponsor Contact Information Luitpold Pharmaceuticals, Inc. 1000 Madison Ave Norristown PA 19403 Generic Name: Doripenem Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/16/2004 Date Approved Johnson & Johnson Pharmaceutical Research & Dev. 920 US Highway 202 P. O. Box 300 Raritan NJ 08869 Generic Name: Dornase alfa Trade Name (if present): Pulmozyme Date Designated 1/16/1991 Date Approved 12/30/1993 Designation Approved: In conjunction with standard therapies in the management of cystic fibrosis patients to reduce the frequency of respiratory infections requiring parenteral antibiotics and to improve pulmonary function. Sponsor Contact Information Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Dovitinib Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/3/2006 Date Approved Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Doxorubicin HCL liposome injection Trade Name (if present): Doxil Date Designated 12/29/2004 Date Approved 5/17/2007 Designation Approved: For use in combination with bortezomib for the treatment of patients with multiple myeloma who have not previously received bortezomib and have at least one prior therapy. Sponsor Contact Information Johnson & Johnson Pharmaceutical Research & Dev. 920 US Highway 202, P. O. Box 300 Raritan NJ 08869 Generic Name: Doxorubicin HCl with pluronic L-61 and pluronic F-127 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/7/2005 Date Approved Supratek Pharma Inc. 215Bouchard Blvd Dorval Quebec H9S 1A9 CANADA Generic Name: Doxorubicin liposome Trade Name (if present): Doxil Date Designated 11/4/1998 Date Approved 6/28/1999 Designation Approved: Treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinium-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment. Sponsor Contact Information Alza Corporation 1550 Plymouth St. PO Box 7210 Mountain View CA 94039-7210 Generic Name: doxorubicin PIHCA nanoparticles Trade Name (if present): Doxorubicin Transdrug Date Designated 3/14/2005 Date Approved Designation Approved: Sponsor Contact Information BioAlliance Pharma 59, Bd Gal Martial Valin - 75015 Paris FRANCE Generic Name: doxorubicin with pluronics F-127 and L-61 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/20/2008 Date Approved Supratek Pharma, Inc. 215 Bouchard Blvd Dorval, Quebec H9S 1A9 CANADA Generic Name: D-peptide of the sequence AKRHHGYKRKFH - NH2 Trade Name (if present): PulmaDex Date Designated 10/23/2002 Date Approved Designation Approved: Sponsor Contact Information Demegen, Inc. 100 Technology Drive Suite 440 B Pittsburgh PA 15219 Generic Name: Dronabinol Trade Name (if present): Marinol Date Designated 1/15/1991 Date Approved 12/22/1992 Designation Approved: Treatment of anorexia associated with weight loss in patients with AIDS. Sponsor Contact Information Unimed Pharmaceuticals, Inc. 901 Sawyer Rd. Marietta GA 30062 Generic Name: Droxidopa Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/17/2007 Date Approved Chelsea Therapeutics, Inc. 13950 Ballantyne Corporate Place Charlotte NC 28277 Generic Name: Duramycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/11/1997 Date Approved Lantibio, Inc. 100 Europa Drive Suite 421 Chapel Hill NC 27517 Generic Name: Dynamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/16/1991 Date Approved Mayo Foundation 200 First Street Southwest Rochester MN 55905 Generic Name: Dynamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/5/1990 Date Approved Mayo Foundation 200 First Street Southwest Rochester MN 55905 Generic Name: eculizumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/5/2001 Date Approved Alexion Pharmaceuticals, Inc. 352 Knotter Drive Cheshire CT 06410 Generic Name: eculizumab Trade Name (if present): Soliris Date Designated 8/20/2003 Date Approved 3/16/2007 Designation Approved: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis Sponsor Contact Information Alexion Pharmaceuticals, Inc. 352 Knotter Drive Cheshire CT 06410 Generic Name: Edotreotide Trade Name (if present): OctreoTher Date Designated 7/28/2005 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaceuticals Corp. 59 Route 10/Bldg 122/N142 One Health Plaza East Hanover NJ 07936-1080 Generic Name: Efaproxiral Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/28/2004 Date Approved Allos Therapeutics, Inc. 11080 CirclePoint Road Suite 200 Westminster CO 80020 Generic Name: Eflornithine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/29/2006 Date Approved VBL Pharmaceuticals, Inc. 216 Robin Way Menlo Park CA 94025 Generic Name: Eflornithine HCl Trade Name (if present): Ornidyl Date Designated 4/18/1986 Date Approved Designation Approved: Sponsor Contact Information Marion Merrell Dow, Inc. P.O. Box 9627 Kansas City MO 64134 Generic Name: Eflornithine HCl Trade Name (if present): Ornidyl Date Designated 4/23/1986 Date Approved 11/28/1990 Designation Approved: Sponsor Contact Information Hoechst Marion Roussel P.O. Box 9627 Kansas City MO 64134 Generic Name: Elcatonin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/25/1995 Date Approved Innapharma, Inc. 10 Mountainview Road Upper Saddle River NJ 07458 Generic Name: Enadoline hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/28/1997 Date Approved Warner-Lambert Company Parke-Davis Pharmaceutical Research Division 2800 Plymouth Road Ann Arbor MI 48105 Generic Name: Encapsulated porcine islet preparation Trade Name (if present): BetaRx Date Designated 7/5/1995 Date Approved Designation Approved: Sponsor Contact Information VivoRx 2825 Santa Monica Blvd. 2nd Floor Santa Monica CA 90404-2429 Generic Name: eniluracil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/15/2005 Date Approved Adherex Technologies, Inc. 4620 Creekstone Drive Research Triangle Park Durham NC 27703 Generic Name: Enisoprost Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/20/1989 Date Approved G.D. Searle & Company 4901 Searle Parkway Skokie IL 60077 Generic Name: Enisoprost Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/20/1989 Date Approved G.D. Searle & Company 4901 Searle Parkway Skokie IL 60077 Generic Name: Enteric-coated cysteamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/24/2006 Date Approved Univ of Cal. San Diego Medical Center, Hillcrest Div. of Gastroenterology, Hepathology, Nutrition 200 West Arbor Drive San Diego CA 92103-8450 Generic Name: Enzastaurin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/19/2005 Date Approved Eli Lilly and Company Lilly Corporate Center Indianapolis IN 46285 Generic Name: Epidermal growth factor (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/5/1987 Date Approved Chiron Vision 500 Iolab Drive Claremont CA 91711 Generic Name: Epidermal growth factor (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/6/1985 Date Approved Ethicon, Inc. P.O. Box 151 Somerville NJ 08876 Generic Name: Epirubicin Trade Name (if present): Ellence Date Designated 9/14/1999 Date Approved 9/15/1999 Designation Approved: Component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. Sponsor Contact Information Pharmacia & Upjohn Company 0634-298-113 7000 Portage Rd. Kalamazoo MI 49001-0199 Generic Name: Epoetin alfa Trade Name (if present): Epogen Date Designated 7/1/1991 Date Approved 12/31/1990 Designation Approved: Treatment of AZT-induced anemia in HIV infected patients. Sponsor Contact Information Amgen, Inc. 1840 Dehavilland Drive Thousand Oaks CA 91320 Generic Name: Epoetin alfa Trade Name (if present): Epogen Date Designated 4/10/1986 Date Approved 6/1/1989 Designation Approved: Sponsor Contact Information Amgen, Inc. 1840 Dehavilland Drive Thousand Oaks CA 91320 Generic Name: Epoetin alfa Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/20/1993 Date Approved Johnson & Johnson Pharmaceutical Research & Dev., 920 U.S. Highway Route 202, P.O. Box 300 Raritan NJ 08869-0602 Generic Name: Epoetin alpha Trade Name (if present): Procrit Date Designated 8/27/1987 Date Approved Designation Approved: Sponsor Contact Information R. W. Johnson Pharmaceutical Research Institute Route 202 South P.O. Box 300 Raritan NJ 08869 Generic Name: Epoetin alpha Trade Name (if present): Procrit Date Designated 7/21/1988 Date Approved Designation Approved: Sponsor Contact Information Johnson & Johnson Pharmaceutical R & D, LLC 920 US Highway 202 P.O. Box 300 Raritan NJ 08869-0602 Generic Name: Epoetin alpha Trade Name (if present): Procrit Date Designated 3/7/1989 Date Approved Designation Approved: Sponsor Contact Information R. W. Johnson Pharmaceutical Research Institute Route 202, P.O. Box 300 Raritan NJ 08869 Generic Name: Epoetin beta Trade Name (if present): Marogen Date Designated 10/22/1987 Date Approved Designation Approved: Sponsor Contact Information Chugai-USA, Inc. 3780 Hawthorn Court Waukegan IL 60087 Generic Name: Epoprostenol Trade Name (if present): Flolan Date Designated 3/22/1999 Date Approved 4/14/2000 Designation Approved: For the long-term intravenous treatment of pulmonary hypertension associated with the scleroderma spectrum of disease in New York Heart Association (NYHA) Class III and Class IV patients who do not respond adequately to conventional therapy. Sponsor Contact Information GlaxoSmithKline Five Moore Dr. PO Box 13398 Research Triangle Park NC 27709-3398 Generic Name: Epoprostenol Trade Name (if present): Flolan Date Designated 9/25/1985 Date Approved 9/20/1995 Designation Approved: Long-term intravenous treatment of primary pulmonary hypertension in NYHA Class III and Class IV patients. Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Epoprostenol Trade Name (if present): Flolan Date Designated 3/29/1984 Date Approved Designation Approved: Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Epoprostenol Trade Name (if present): Cycloprostin Date Designated 10/29/1984 Date Approved Designation Approved: Sponsor Contact Information Upjohn Company 301 Henrietta Street Kalamazoo MI 49001 Generic Name: epratuzumab Trade Name (if present): LymphoCIDE Date Designated 7/13/1998 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Eprodisate Trade Name (if present): Fibrillex Date Designated 4/6/1999 Date Approved Designation Approved: Sponsor Contact Information Neurochem, Inc. 7220 Frederick Banting, Suite 100 Saint-Laurent Quebec H4S 2A1 CANADA Generic Name: Epstein Barr Virus specific cytotoxic T lymphocytes Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/27/2006 Date Approved Center for Cell and Gene Therapy Feigin Center Suite 1120 Houston TX 77030-2399 Generic Name: Erlotinib Hydrochloride Trade Name (if present): Tarceva Date Designated 7/18/2003 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc 1 DNA Way South San Francisco CA 94080-4990 Generic Name: Erwinia L-asparaginase Trade Name (if present): Erwinase Date Designated 7/30/1986 Date Approved Designation Approved: Sponsor Contact Information EUSA Pharma (US), Inc. 1980 South Easton Road Suite 250 Doylestown PA 18901 Generic Name: Erwinia L-asparaginase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/25/1985 Date Approved Lyphomed, Inc. Generic Name: Erythropoietin (human, recombinant) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/19/1987 Date Approved Organon Teknika Corporation Generic Name: Erythropoietin (recombinant human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/19/1987 Date Approved McDonnell Douglas Corp P.O. Box 516, 107/2 MS10 St. Louis MO 63166 Generic Name: Estradiol Gel Trade Name (if present): EstroGel Date Designated 10/31/2006 Date Approved Designation Approved: Sponsor Contact Information Ascend Therapeutics, Inc. 607 Herndon Parkway Herndon VA 21070 Generic Name: Etanercept Trade Name (if present): Enbrel Date Designated 4/6/1999 Date Approved Designation Approved: Sponsor Contact Information Immunex Corporation 51 University Street Seattle WA 98101-2936 Generic Name: etanercept Trade Name (if present): Enbrel Date Designated 10/27/1998 Date Approved 5/27/1999 Designation Approved: Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. Sponsor Contact Information Immunex Corporation 51 University St. Seattle WA 98101-2936 Generic Name: Ethanol gel Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/13/2006 Date Approved Orfagen Parc Technologique du Canal 31521 Ramonville Saint Agne Cedex FRANCE Generic Name: Ethanol gel Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/29/2006 Date Approved Orfagen Parc Technologique du Canal 31521 Ramonville Saint Agne Cedex FRANCE Generic Name: Ethanolamine oleate Trade Name (if present): Ethamolin Date Designated 3/22/1984 Date Approved 12/22/1988 Designation Approved: Sponsor Contact Information Block Drug Company, Inc. 257 Cornelison Avenue Jersey City NJ 07302 Generic Name: Ethinyl Estradiol, USP Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/22/1988 Date Approved Bio-Technology General Corp. 70 Wood Avenue, South Iselin NJ 08830 Generic Name: Ethiofos Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/1/1989 Date Approved U.S. Bioscience 100 Front Street West Conshohocken PA 19428 Generic Name: Ethyl eicosapentaenoate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/6/2000 Date Approved Laxdale Ltd. Kings Park House, Laurelhill Business Park Polmaise Road, Stirling FK7 9JQ UNITED KINGDOM Generic Name: Etidronate disodium Trade Name (if present): Didronel IV infusion Date Designated 5/2/1991 Date Approved Designation Approved: Sponsor Contact Information MGI Pharma, Inc. 6300 West Old Shakoppe Rd. Suite 110 Bloomington MN 55438-2318 Generic Name: Etidronate disodium Trade Name (if present): Didronel IV Infusion Date Designated 5/2/1991 Date Approved Designation Approved: Sponsor Contact Information MGI Pharma, Inc. 6300 West Old Shakoppe Rd. Suite 110 Bloomington MN 55438-2318 Generic Name: Etidronate disodium Trade Name (if present): Didronel Date Designated 3/21/1986 Date Approved 4/21/1987 Designation Approved: Sponsor Contact Information MGI Pharma, Inc. 5775 West Old Shakoppe Rd. Suite 100 Bloomington MN 55437-3107 Generic Name: Etiocholanedione Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/7/1996 Date Approved SuperGen, Inc. Two Annabel Lane, Suite 220 San Ramon CA 94583 Generic Name: Etiocholanedione Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/3/1995 Date Approved SuperGen, Inc. Two Annabel Lane, Suite 220 Suite 10 San Ramon CA 94583 Generic Name: everolimus Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/14/2008 Date Approved Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Ex vivo cultured adult human mesenchymal stem cells Trade Name (if present): Prochymal Date Designated 12/14/2005 Date Approved Designation Approved: Sponsor Contact Information Osiris Therpeutics, Inc. 2001 Aliceanna Street Baltimore MD 21231-3043 Generic Name: Exemestane Trade Name (if present): Aromasin Date Designated 9/19/1991 Date Approved 10/21/1999 Designation Approved: Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Mail Stop: 0636-298-113 Kalamazoo MI 49001-0199 Generic Name: Exisulind Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/14/1994 Date Approved OSI Pharmaceuticals, Inc. 58 South Service Road Suite 110 Melville NY 11747 Generic Name: Factor XIII [A2] homodimer, recombinant DNA origin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/21/2003 Date Approved Novo Nordisk Pharmaceuticals, INc. 100 College Road West Princeton NJ 08540 Generic Name: Factor XIII [A2} homodimer, recombinant DNA origin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/6/2003 Date Approved Novo Nordisk, Inc. 100 College Road West Princeton NJ 08540 Generic Name: factor XIII concentrate (human), pasteurized Trade Name (if present): Fibrogammin P Date Designated 1/16/1985 Date Approved Designation Approved: Sponsor Contact Information CSL Behring L.L.C. 1020 First Ave. PO Box 61501 King of Prussia PA 19406-0901 Generic Name: Factor XIII, recombinant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/22/1993 Date Approved Zymogenetics, Inc. 4225 Roosevelt Way Seattle WA 98105 Generic Name: Fampridine Trade Name (if present): Neurelan Date Designated 6/2/1997 Date Approved Designation Approved: Sponsor Contact Information Acorda Therapeutics, Inc. 15 Skyline Dr. Hawthorne NY 10532 Generic Name: Fampridine Trade Name (if present): Neurelan Date Designated 6/2/1987 Date Approved Designation Approved: Sponsor Contact Information Acorda Therapeutics 15 Skyline Dr. Hawthorne NY 10532 Generic Name: Felbamate Trade Name (if present): Felbatol Date Designated 1/24/1989 Date Approved 7/29/1993 Designation Approved: As adjunctive therapy in the treatment of partial and generalized seizures associated with the Lennox-Gastaut syndrome in children. Sponsor Contact Information Wallace Laboratories 301B College Road East Princeton NJ 08540 Generic Name: Fenobam hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/20/2006 Date Approved Neuropharm, Ltd. Fetcham Park House Leatherhead, Surrey KT22 9HD UNITED KINGDOM Generic Name: fenretinide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/2007 Date Approved Cancer Research UK 61 Lincoln's Inn Fields London WC2A 3PX UNITED KINGDOM Generic Name: Fenretinide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/5/2005 Date Approved USC-CHLA Institute for Pediatric Clinical Research Childrens Hospital Los Angeles 4650 Sunset Blve, MS 55 Los Angeles CA 90027 Generic Name: ferric hexacyanoferrate (II) "Prussian Blue" Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/26/2003 Date Approved Degussa AG Weissfrauenstr.9 D-60287 Frankfurt GERMANY Generic Name: FIAU Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/24/1992 Date Approved Oclassen Pharmaceuticals, Inc. 100 Pelican Way San Rafael CA 94901 Generic Name: Fibrinogen (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/23/1995 Date Approved Alpha Therapeutic Corporation 5555 Valley Boulevard Los Angeles CA 90032 Generic Name: Fibronectin (human plasma derived) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/5/1988 Date Approved Melville Biologics, Inc. 310 East 67th Street New York NY 10021 Generic Name: Fibronectin (plasma derived) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/5/1988 Date Approved Chiron Vision 9342 Jeronimo Road Irvine CA 92718 Generic Name: Filgrastim Trade Name (if present): Neupogen Date Designated 11/7/1990 Date Approved 12/19/1994 Designation Approved: Treatment of patients with severe chronic neutropenia. Sponsor Contact Information Amgen, Inc. 1840 Dehavilland Drive Thousand Oaks CA 91320 Generic Name: Filgrastim Trade Name (if present): Neupogen Date Designated 8/30/1990 Date Approved Designation Approved: Sponsor Contact Information Amgen, Inc. 1840 Dehavilland Drive Thousand Oaks CA 91320 Generic Name: Filgrastim Trade Name (if present): Neupogen Date Designated 10/1/1990 Date Approved 6/15/1994 Designation Approved: Reduce the duration of neutropenia and neutropenia sequelae in patients with non-myeloid malignancies undergoing ablative chemotherapy followed by BMT. Sponsor Contact Information Amgen, Inc. 1840 Dehavilland Drive Thousand Oaks CA 91320 Generic Name: Filgrastim Trade Name (if present): Neupogen Date Designated 11/7/1996 Date Approved 4/2/1998 Designation Approved: Reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia. Sponsor Contact Information Amgen, Inc. One Amgen Center Dr. Thousand Oaks CA 91320-1799 Generic Name: Filgrastim Trade Name (if present): Neupogen Date Designated 9/3/1991 Date Approved Designation Approved: Sponsor Contact Information Amgen, Inc. One Amgen Center Dr. Thousand Oaks CA 91320-1799 Generic Name: Filgrastim Trade Name (if present): Neupogen Date Designated 7/17/1995 Date Approved 12/28/1995 Designation Approved: For use in the mobilization of hematopoietic progenitor cells into the peripheral blood collection by leukapheresis. Sponsor Contact Information Amgen, Inc. 1840 Dehavilland Drive Thousand Oaks CA 91320 Generic Name: Floxuridine, FUDR Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/22/2004 Date Approved Franco Muggia, M.D. 160 East 34th Street New York NY 10016 Generic Name: Fludarabine phosphate Trade Name (if present): Fludara Date Designated 4/18/1989 Date Approved 4/18/1991 Designation Approved: Sponsor Contact Information Berlex Laboratories, Inc. 15049 San Pablo Avenue, P.O. Box 4099 Richmond CA 94804 Generic Name: Fludarabine phosphate Trade Name (if present): Fludara Date Designated 4/18/1989 Date Approved Designation Approved: Sponsor Contact Information Berlex Laboratories, Inc. 15049 San Pablo Avenue P.O. Box 4099 Richmond CA 94804-0099 Generic Name: Fludarabine phosphate oral tablets Trade Name (if present): Designation Approved: Major contribution to patient care. IV to oral Sponsor Contact Information Date Designated 12/18/2007 Date Approved Xanthus Pharmaceuticals, Inc. 300 Technology Square Cambridge MA 02139 Generic Name: Flumecinol Trade Name (if present): Zixoryn Date Designated 1/15/1985 Date Approved Designation Approved: Sponsor Contact Information Farmacon, Inc. Post House, Suite 213 1720 Post Road East Westport CT 06880-5643 Generic Name: Flunarizine Trade Name (if present): Sibelium Date Designated 1/6/1986 Date Approved Designation Approved: Sponsor Contact Information Janssen Research Foundation P.O. Box 200 Titusville NJ 08560 Generic Name: Fluocinolone Trade Name (if present): Retisert Date Designated 7/31/2000 Date Approved 4/8/2005 Designation Approved: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye Sponsor Contact Information Bausch & Lomb Pharmaceuticals, Inc. 8500 Hidden River Parkway Tampa FL 33637 Generic Name: Fluorouracil Trade Name (if present): Adrucil Date Designated 2/6/1989 Date Approved Designation Approved: Sponsor Contact Information Lederle Laboratories Division of American Cyanamid Company 401 N. Middletown Road Pearl River NY 10965 Generic Name: Fluorouracil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/27/1989 Date Approved Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110-1199 Generic Name: Fluorouracil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/18/1990 Date Approved Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110-1199 Generic Name: Fluorouracil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/29/2000 Date Approved Ethypharm SA 194 Bureaux de la Colline - Batiment D 92213 Saint-Cloud Cedex Generic Name: Fluoxetine Trade Name (if present): Prozac Date Designated 4/14/2004 Date Approved Designation Approved: Sponsor Contact Information Hollander, Eric MD The Mount Sinai School of Medicine One Gustave L. Levy Place New York NY 10029-6574 Generic Name: Fluoxetine Trade Name (if present): Prozac Date Designated 4/30/1999 Date Approved Designation Approved: Sponsor Contact Information Mt. Sinai School of Medicine Dept. of Psychiatry Box 1230, One Gustave L. Levy Place New York NY 10029-6574 Generic Name: Follitropin alfa, recombinant Trade Name (if present): Gonal-F Date Designated 12/21/1998 Date Approved 5/24/2000 Designation Approved: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. Sponsor Contact Information Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Fomepizole Trade Name (if present): Antizole Date Designated 12/22/1988 Date Approved 12/8/2000 Designation Approved: Use for suspected or confirmed methanol poisoning, either alone or in combination with hemodialysis Sponsor Contact Information Jazz Pharmaceuticals 3180 Porter Drive Palo Alto CA 94304 Generic Name: Fomepizole Trade Name (if present): Antizole Date Designated 12/22/1988 Date Approved 12/4/1997 Designation Approved: As an antidote to ethylene glycol (antifreeze) poisoning, or for use in suspected ethylene glycol ingestion. Sponsor Contact Information Jazz Pharmaceuticals 3180 Porter Drive Palo Alto CA 94304 Generic Name: Fosphenytoin Trade Name (if present): Cerebyx Date Designated 6/4/1991 Date Approved 8/5/1996 Designation Approved: For the control of generalized convulsive status epilepticus. Sponsor Contact Information Warner-Lambert Company 2800 Plymouth Road Ann Arbor MI 48106 Generic Name: Fructose-1,6-diphosphate Trade Name (if present): Cordox Date Designated 5/29/1998 Date Approved Designation Approved: Sponsor Contact Information Questcor Pharmaceuticals, Inc. 3260 Whipple Road Union City CA 94587-1217 Generic Name: Fully Human Anti-MCP-1/CCL2 Monoclonal Antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/8/2007 Date Approved Centocor, Inc. 200 Great Vallley Parkway Malvern PA 19355-1307 Generic Name: Fusion protein consisting of human immunoglobim G1 constant region Fc region fused to the human receptor binding domain of ectodysplasin-A1 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/11/2006 Date Approved Apoxis SA Av de Sevelin, 18-20 Lausanne, Switzerland Generic Name: G17DT Immunogen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/18/2002 Date Approved Receptor BioLogix, Inc. 1140 Veterans Blvd. Suite A South San Francisco CA 94080 Generic Name: G17DT Immunogen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/10/2002 Date Approved Receptor BioLogix, Inc. 1140 Veterans Blvd. Suite A South San Francisco CA 94080 Generic Name: Gabapentin Trade Name (if present): Neurontin Date Designated 7/5/1995 Date Approved Designation Approved: Sponsor Contact Information Warner-Lambert Company Parke-Davis Pharmaceutical Research Division 2800 Plymouth Road Ann Arbor MI 48105 Generic Name: Gallium nitrate injection Trade Name (if present): Ganite Date Designated 12/5/1988 Date Approved 1/17/1991 Designation Approved: Sponsor Contact Information Solopak Pharmaceutical Co. 1845 Tonne Road Elk Grove Village IL 60007 Generic Name: Gamma hydroxybutyrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/3/1987 Date Approved Biocraft Laboratories, Inc. 18-01 River Road Fair Lawn NJ 07410 Generic Name: Gamma-hydroxybutyric acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/22/1985 Date Approved Sigma Chemical Company Generic Name: Gammalinolenic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/27/1994 Date Approved Zurier, Robert B. M.D. University of Massachusetts Medical Center 55 Lake Avenue Worcester MA 01655 Generic Name: Ganaxolone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/25/1994 Date Approved Marinus Pharmaceuticals, Inc. 21 Business Park Drive Branford CT 06405 Generic Name: Ganciclovir Trade Name (if present): Virgan Date Designated 3/22/2007 Date Approved Designation Approved: Sponsor Contact Information Sirion Therapeutics, Inc. 3110 Cherry Palm Drive Tampa FL 33619 Generic Name: Ganciclovir intravitreal implant Trade Name (if present): Vitrasert Implant Date Designated 6/7/1995 Date Approved 3/4/1996 Designation Approved: Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome. Sponsor Contact Information Bausch & Lomb Surgical, Chiron Vision Products 9342 Jeronimo Road Irvine CA 92718-1903 Generic Name: Ganciclovir sodium Trade Name (if present): Cytovene Date Designated 10/31/1985 Date Approved 6/23/1989 Designation Approved: Sponsor Contact Information Syntex (USA), Inc. 3401 Hillview Avenue Palo Alto CA 94304 Generic Name: Gancyclovir Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/7/1985 Date Approved Burroughs Wellcome Company 3030 Cornwallis Road P.O. Box 12700 Research Triangle Park NC 27709 Generic Name: Gangliosides as sodium salts Trade Name (if present): Cronassial Date Designated 11/17/1988 Date Approved Designation Approved: Sponsor Contact Information Fidia Pharmaceutical Corp. 1401 Eye Street, N.W. Suite 900 Washington DC 20005 Generic Name: Gavilimomab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/20/2000 Date Approved Amgen One Amgen Center Drive Mail Stop 17-2-A Thousand Oaks CA 91320-1799 Generic Name: Gemtuzumab zogamicin Trade Name (if present): Mylotarg Date Designated 11/24/1999 Date Approved 5/17/2000 Designation Approved: Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy Sponsor Contact Information Wyeth-Ayerst Laboratories PO Box 8299 Philadelphia PA 19101-8299 Generic Name: Gene plasmid hVEGF165 driven by human cytomegalovirus, and [2,3bis(oleoyl)propyl]trimethyl ammonium and dioleoyl phosphatidyl ethanolamine Trade Name (if present): Trinam Date Designated 10/24/2000 Date Approved Designation Approved: Sponsor Contact Information Ark Therapeutics Ltd. 1 Fitzroy Mews London W1T6DE UNITED KINGDOM Generic Name: genetically engineered herpes simplex virus (G207) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/29/2002 Date Approved MediGene, Inc. 10660 Scripps Ranch Blvd. Suite 200 San Diego CA 92131 Generic Name: Geneticin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/6/2005 Date Approved ProcesScience, Inc (PSI) 505 Irving Avenue Syracuse NY 13210 Generic Name: Gentamicin impregnated PMMA beads on surgical wire Trade Name (if present): Septopal Date Designated 1/31/1991 Date Approved Designation Approved: Sponsor Contact Information Lipha Pharmaceuticals, Inc. 9 West 57th Street Suite 3825 New York NY 10019-2701 Generic Name: Gentamicin liposome injection Trade Name (if present): Maitec Date Designated 7/10/1990 Date Approved Designation Approved: Sponsor Contact Information Liposome Company, Inc. One Research Way Princeton NJ 08540 Generic Name: glatiramer acetate Trade Name (if present): Copaxone Date Designated 11/14/2007 Date Approved Designation Approved: Sponsor Contact Information Teva Neurosciences, Inc. P. O. Box 1005 Horsham PA 19044-8005 Generic Name: Glatiramer acetate Trade Name (if present): Copaxone Date Designated 11/9/1987 Date Approved 12/20/1996 Designation Approved: For reduction of the frequency of relapses in patients with relapsingremitting multiple sclerosis. Sponsor Contact Information Teva Pharmaceuticals USA 1510 Delp Drive Kulpsville PA 19443 Generic Name: Glatiramer acetate for injection Trade Name (if present): Copaxone Date Designated 6/5/2001 Date Approved Designation Approved: Sponsor Contact Information TEVA Pharmaceuticals, USA 1090 Horsham Road North Wales PA 19454 Generic Name: glucarpidase Trade Name (if present): Voraxaze Date Designated 8/19/2003 Date Approved Designation Approved: Sponsor Contact Information Protherics, Inc. 5214 Maryland Way, Suite 405 Brentwood TN 37027 Generic Name: glufosfamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/18/2006 Date Approved Threshold Pharmaceuticals, Inc. 1300 Seaport Blvd. Redwood City CA 94063 Generic Name: Glutamine Trade Name (if present): NutreStore Date Designated 3/6/1995 Date Approved 6/10/2004 Designation Approved: Treatment of short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with a rercombinant human growth hormone that is approved for this indication. Sponsor Contact Information Nutritional Restart Pharmaceutical, L.P. 4364 South Alston Avenue Durham NC 27713 Generic Name: Glyceol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/22/1990 Date Approved Chugai Pharmaceutical Co., Ltd. Generic Name: Glyceryl tri (4-phenylbutyrate) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/24/2005 Date Approved Ucyclyd Pharma, Inc Subsidiary of Medicis Pharmaceutical Corporation Scottsdale AZ 85258 Generic Name: Glyceryl trioleate and glyceryl trierucate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/14/1995 Date Approved Moser, Hugo W. M.D. Johns Hopkins University Kennedy Krieger Institute, 707 North Broadway Baltimore MD 21205 Generic Name: Glycopyrrolate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/9/2006 Date Approved Sciele Pharma, Inc. Five Concourse Parkway Suite 1800 Atlanta GA 30328 Generic Name: Golimumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/2/2004 Date Approved Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: Gonadorelin acetate Trade Name (if present): Lutrepulse Date Designated 4/22/1987 Date Approved 10/10/1989 Designation Approved: Sponsor Contact Information Ferring Laboratories, Inc. 400 Rella Boulevard, Suite 201 Suffern NY 10901 Generic Name: Gossypol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/22/1990 Date Approved Reidenberg, Marcus M. M.D. The New York Hospital - Cornell Medical Center 525 East 68th Street, Box 70 New York NY 10021 Generic Name: Gp100 adenoviral gene therapy Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/25/1997 Date Approved Genzyme Corporation 500 Kendall Street Cambridge MA 02142 Generic Name: Granulocyte macrophage-colony stimulating factor Trade Name (if present): Leucomax Date Designated 6/6/1989 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Granulocyte macrophage-colony stimulating factor Trade Name (if present): Leucomax Date Designated 5/4/1990 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Granulocyte macrophage-colony stimulating factor Trade Name (if present): Leucomax Date Designated 8/7/1989 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Granulocyte macrophage-colony stimulating factor Trade Name (if present): Leucomax Date Designated 12/12/1989 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Granulocyte macrophage-colony stimulating factor Trade Name (if present): Leucomax Date Designated 5/3/1990 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Group B streptococcus immune globulin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/8/1990 Date Approved North American Biologicals, Inc. 12280 Wilkins Avenue Rockville MD 20852 Generic Name: Growth hormone releasing factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/7/1989 Date Approved Valeant Pharmaceuticals International One Enterprise Way Aliso Viejo CA 92656 Generic Name: Guanethidine monosulfate Trade Name (if present): Ismelin Date Designated 1/6/1986 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover NJ 07936-1080 Generic Name: Guanfacine Trade Name (if present): Tenex Date Designated 8/5/1999 Date Approved Designation Approved: Sponsor Contact Information Watson Laboratories, Inc. 311 Bonnie Circle PO Box 1900 Corona CA 91718-1900 Generic Name: Gusperimus Trade Name (if present): Spanidin Date Designated 6/27/1996 Date Approved Designation Approved: Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute 5 Research Parkway P.O. Box 5100 Wallingford CT 06492-7660 Generic Name: h5G1.1-mAb Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/21/2000 Date Approved Alexion Pharmaceuticals, Inc. 352 Knotter Drive Cheshire CT 06410 Generic Name: Halofantrine Trade Name (if present): Halfan Date Designated 11/4/1991 Date Approved 7/24/1992 Designation Approved: Treatment of adults who can tolerate oral medication and who have mild to moderate malaria caused by Plasmodium falciparum or Plasmodium vivax. Sponsor Contact Information SmithKline Beecham Pharmaceuticals One Franklin Plaza P.O. Box 7929 Philadelphia PA 19101 Generic Name: Halofuginone Trade Name (if present): Stenorol Date Designated 2/7/2000 Date Approved Designation Approved: Sponsor Contact Information Collgard Biopharmaceuticals Ltd. Textile House, 2 Koifman St. Tel-Aviv 68012 ISRAEL Generic Name: heat killed Mycobacterium w immunomodulator Trade Name (if present): CADI Mw Date Designated 9/3/2004 Date Approved Designation Approved: Sponsor Contact Information Cadila Pharmaceuticals Limited, Inc. 9801 Washingtonian Blvd Suite 220 Gaithersburg MD 20878 Generic Name: heat killed mycobacterium w immunomodulator Trade Name (if present): CADI Mw Date Designated 11/21/2002 Date Approved Designation Approved: Sponsor Contact Information CPL, Inc. 16020 Swingley Ridge Road Suite 145 Chesterfield MO 63017 Generic Name: Heme arginate Trade Name (if present): Normosang Date Designated 3/10/1988 Date Approved Designation Approved: Sponsor Contact Information Orphan Europe Immeuble Le Guillaumet 92046 Paris La Defense FRANCE Generic Name: Heme arginate Trade Name (if present): Normosang Date Designated 3/1/1994 Date Approved Designation Approved: Sponsor Contact Information Orphan Europe Immeuble Le Guillaumet 70 avenue du General de Gaulle, 92056 Paris La Defense FRANCE Generic Name: Hemin Trade Name (if present): Panhematin Date Designated 3/16/1984 Date Approved 7/20/1983 Designation Approved: Sponsor Contact Information Abbott Laboratories Diagnostics Division Abbott Park IL 60064 Generic Name: Hemin and zinc mesoporphyrin Trade Name (if present): Hemex Date Designated 12/20/1993 Date Approved Designation Approved: Sponsor Contact Information Bonkovsky, Herbert L. M.D. University Of Massachusetts Medical Center 55 Lake Avenue North Worcester MA 01655 Generic Name: Hemoximer (pyridoxalated hemoglobin polyoxyethylene) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2007 Date Approved Apex Bioscience, Inc. 109 Conner Drive ` Chapel Hill NC 27514 Generic Name: Heparin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/3/2005 Date Approved Vectura Group, Inc. 1 Prospect West Wiltshire SN14 6FH UNITED KINGDOM Generic Name: Heparin sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/29/2006 Date Approved Ockham Biotech Limited Manor Farm 98 Swanwick Lane UNITED KINGDOM Generic Name: Heparin-binding epidermal growth factorlike growth factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/18/2006 Date Approved Trillium Therapeutics, Inc. 96 Skyway Avenue M9W 4Y4 CANADA Generic Name: hepatitis B immune globulin (human) Trade Name (if present): HepaGam Date Designated 3/24/2008 Date Approved 4/6/2007 Designation Approved: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients Sponsor Contact Information Cangene Corporation 155 Innovation Drive CANADA Generic Name: Hepatitis B immune globulin intravenous (human) Trade Name (if present): Nabi-HB Date Designated 3/8/1995 Date Approved Designation Approved: Sponsor Contact Information NABI 12280 Wilkins Avenue Rockville MD 20852 Generic Name: Hepatitis C virus immune globulin (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/14/2002 Date Approved Biotest Pharmaceuticals Corporation 5800 Park of Commerce Blvd, NW Boca Raton FL 33487 Generic Name: HepeX-B Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/15/2003 Date Approved Cubist Pharmaceuticals 65 Hayden Avnue Lexington MA 02421 Generic Name: Herpes simplex virus gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/16/1992 Date Approved Genetic Therapy, Inc. 938 Clopper Road Gaithersburg MD 20878 Generic Name: Histamine Trade Name (if present): Maxamine Date Designated 2/1/2000 Date Approved Designation Approved: Sponsor Contact Information EpiCept Corporation 777 Old Saw Mill River Road Tarrytown NY 10591 Generic Name: Histamine Trade Name (if present): Ceplene Date Designated 12/15/1999 Date Approved Designation Approved: Sponsor Contact Information EpiCept Corporation 777 Old Saw Mill River Road Tarrytown NY 10591 Generic Name: Histrelin Trade Name (if present): Supprelin LA Date Designated 11/18/2005 Date Approved 5/3/2007 Designation Approved: Treatment of central precocious puberty Sponsor Contact Information Indevus Pharmaceuticals (Formerly Valera Pharma.) 33 Hayden Avenue Lexington MA 02421 Generic Name: Histrelin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/3/1991 Date Approved Anderson, Karl E., M.D. University of Texas Medical Branch at Galveston Route J-09, 700 The Strand Galveston TX 77550 Generic Name: Histrelin acetate Trade Name (if present): Supprelin Injection Date Designated 8/10/1988 Date Approved 12/24/1991 Designation Approved: Treatment of central precocious puberty. Sponsor Contact Information Roberts Pharmaceutical Corp. Meridian Center III 6 Industrial Way West Eatontown NJ 07724 Generic Name: HIV neutralizing antibodies Trade Name (if present): Immupath Date Designated 3/24/1992 Date Approved Designation Approved: Sponsor Contact Information Hemacare Corporation 4954 Van Nuys Boulevard Sherman Oaks CA 91403 Generic Name: HLA-B7/Beta2M DNA Lipid (DMRIE/DOPE) Complex Trade Name (if present): Allovectin-7 Date Designated 9/30/1999 Date Approved Designation Approved: Sponsor Contact Information Vical Incorporated 9373 Towne Centre Dr., Suite 100 San Diego CA 92121 Generic Name: homoharringtonine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/8/2002 Date Approved American BioScience, Inc. 2730 Wilshire Blvd. #110 Santa Monica CA 90403 Generic Name: HPA-23 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/17/1985 Date Approved Rhone-Poulenc Rorer Pharm. 500 Arcola Road Collegeville PA 19426 Generic Name: Hsp E7 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/19/2001 Date Approved StressGen Biotechnologies, Inc. is now Nventa Nventa Biopharmaceuticals Corporation 6055 Lusk Boulevard San Diego CA 19426-2655 Generic Name: Hu1D10, humanized monoclonal antibody Trade Name (if present): Remitogen Date Designated 11/28/2001 Date Approved Designation Approved: Sponsor Contact Information PDL BioPharma, Inc. 34801 Campus Drive Fremont CA 94555 Generic Name: Human acid precursor alpha-glucosidase, recombinant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/10/1996 Date Approved Pharming/Genzyme LLC c/o Genzyme Corporation 1 Mountain Rd. Framingham MA 01701-9322 Generic Name: Human alpha 2,6 sialyltransferase adenoviral gene therapy Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/4/2005 Date Approved Falk Center for Molecular Therapeutics 1801 Maple Avenue Suite 4300 Evanston IL 60201 Generic Name: Human anti-CD30 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/27/2004 Date Approved Medarex, Inc. 519 Route 173 West Bloomsbury NJ 08804 Generic Name: human anti-CD4 monoclonal antibody Trade Name (if present): HuMax-CD4 Date Designated 8/13/2004 Date Approved Designation Approved: Sponsor Contact Information Genmab A/S Tolbodgade 33 DK-1253 Copenhagen K DENMARK Generic Name: Human anti-integrin receptor av monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/5/2005 Date Approved Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: human anti-integrin receptor avb3/avb5 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/1/2004 Date Approved Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: human anti-transforming growth factor beta 1 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/11/2002 Date Approved Genzyme Corporation One Kendall Square Cambridge MA 02139 Generic Name: human anti-transforming growth factorB1,2,3 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/9/2004 Date Approved Genzyme Corporation 500 Kendall Street Cambridge MA 02142 Generic Name: Human autologous bone-forming cell derived from bone marrow stem cells Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/24/2008 Date Approved Bone Therapeutics S.A. 8, rue Adrienne Bolland BELGIUM Generic Name: human coagulation factor XI Trade Name (if present): Hemoleven Date Designated 11/8/2007 Date Approved Designation Approved: Sponsor Contact Information Laboratoire francais du Fractionnement et des Biot 3 Avenue des Tropiques 91985 Courtaboeuf Cedex FRANCE Generic Name: Human cytomegalovirus immunoglobulin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/20/2006 Date Approved Biotest Diagnostics Corporation 66 Ford Road Denville NJ 07834 Generic Name: Human factor X Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/8/2007 Date Approved Bio Products Laboratory Dagger Lane Hertfordshire, WD6 3BX UNITED KINGDOM Generic Name: Human fibrinogen concentrate, pasteurized Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/13/2008 Date Approved CSL Behring, LLC 1020 First Avenue King of Prussia PA 19406 Generic Name: human gammaglobulin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/16/2002 Date Approved Protein Therapeutics, Inc. 70 Calle Encanto Tucson AZ 85716 Generic Name: human gammaglobulin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/14/2003 Date Approved Protein Therapeutics, Inc. 70 Calle Encanto Tucson AZ 85716 Generic Name: human gammaglobulin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/25/2001 Date Approved Protein Therapeutics, Inc. 70 Calle Encanto Tuscon AZ 85716 Generic Name: Human IgM monoclonal antibody (C-58) To CMV Trade Name (if present): Centovir Date Designated 8/7/1989 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 244 Great Valley Parkway Malvern PA 19355 Generic Name: Human IgM monoclonal antibody (C-58) To CMV Trade Name (if present): Centovir Date Designated 8/7/1989 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 244 Great Valley Parkway Malvern PA 19355 Generic Name: Human immune globulin Trade Name (if present): Xepol Date Designated 3/29/2006 Date Approved Designation Approved: Sponsor Contact Information Pharmalink AB P. O. Box 625 SWEDEN Generic Name: Human immunodeficiency virus immune globulin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/21/1989 Date Approved NABI 5800 Park of Commerce Blvd., NW Boca Raton FL 33487 Generic Name: Human immunodeficiency virus immune globulin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/25/1992 Date Approved NABI 5800 Park of Commerce Blvd., N.W. Boca Raton FL 33487 Generic Name: Human immunodeficiency virus immune globulin Trade Name (if present): Hivig Date Designated 1/4/1995 Date Approved Designation Approved: Sponsor Contact Information NABI 5800 Park of Commerce Blvd., NW Boca Raton FL 33487 Generic Name: Human immunoglobin anti-CD30 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/10/2006 Date Approved Medarex, Inc. 519 Route 173 West Bloomsbury NJ 08804 Generic Name: Human immunoglobulin (IgG1k)antiCTLA-4 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/3/2004 Date Approved Bristol-Myers Squibb Pharmaceutical Research Insti 5 Research Parkway Signature 91 Bldg/3SIG-3012 Wallingford CT 06492 Generic Name: human leukocyte-derived cytokine mixture Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/7/2005 Date Approved IRX Therapeutics, Inc. 140 West 57th Street New York City NY 10019 Generic Name: Human monoclonal antibody against platelet-derived growth factor D Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/2/2004 Date Approved CuraGen Corporation 322 East Main Street Branford CT 06405 Generic Name: Human monoclonal antibody directed against serotype 011 Pseudomonas Trade Name (if present): Aerumab 11 Date Designated 9/18/2006 Date Approved Designation Approved: Sponsor Contact Information Kenta Biotech Limited Rehhagstrsase SWITZERLAND Generic Name: Human monoclonal antibody of the Ig1/kisotype against human interleukin-1 beta Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2007 Date Approved Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Human monoclonal antibody targeting CCchemokine ligand 2 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/24/2006 Date Approved Centocor, Inc. 200 Great Valley PArkway Malvern PA 19355-1307 Generic Name: Human plasma coagulation Factor VIII and human plasma von Willebrand Factor Trade Name (if present): Wilate Date Designated 4/18/2007 Date Approved Designation Approved: Sponsor Contact Information Octapharma USA, Inc. 121 River Street 12th Floor Hoboken NJ 07030 Generic Name: Human prothrombin complex concentrate Trade Name (if present): Octaplex Date Designated 2/1/2008 Date Approved Designation Approved: Sponsor Contact Information Octapharma USA, Inc. 121 River Street 12th Floor Hoboken NJ 07030 Generic Name: Human telomerase reverse transcriptase peptide vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/20/2006 Date Approved Pharmexa A/S Koigle Alle 6 DENMARK Generic Name: Human T-lymphotropic virus type III Gp160 antigens Trade Name (if present): Vaxsyn HIV-1 Date Designated 11/20/1989 Date Approved Designation Approved: Sponsor Contact Information MicroGeneSys, Inc. 1000 Research Parkway Meriden CT 06450 Generic Name: Human umbilical tissue-derived cells Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/13/2006 Date Approved Centocor, Inc 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: Humanized anti-CD2 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/13/1998 Date Approved MedImmune, Inc. 35 West Watkins Mill Rd. Gaithersburg MD 20878 Generic Name: Humanized anti-CD3 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/29/2006 Date Approved MacroGenics, Inc. 1500 East Gude Drive Rockville MD 20850 Generic Name: humanized anti-human CD16 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/21/2005 Date Approved Genzyme Corporation 500 Kendall Street Cambridge MA 02142 Generic Name: Humanized anti-human CD2 MAb Trade Name (if present): MEDI-507 Date Designated 9/17/1998 Date Approved Designation Approved: Sponsor Contact Information Biotransplant, Inc. Building 75, 3rd. Ave. Charlestown Navy Yard Charlestown MA 02129 Generic Name: Humanized anti-tac Trade Name (if present): Zenapax Date Designated 3/5/1993 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110-1199 Generic Name: Humanized MAb (IDEC-131) to CD40L Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/9/1999 Date Approved Biogen IdecInc. 3030 Callan Rd. San Diego CA 92121 Generic Name: humanized monoclonal antibody against Shiga-like toxin II Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/12/2001 Date Approved Teijin America, Inc. 600 Alexander Park Suite 304 Princeton NJ 08540 Generic Name: Humanized monoclonal antibody to the high affinity folate alpha receptor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/16/2006 Date Approved Morphotek, Inc. 210 Welsh Pool Road Exton PA 19341 Generic Name: hyaluronic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/19/2002 Date Approved Exhale Therapeutics, Inc. 1301 Shoreway Road Suite 320 Belmont CA 94002 Generic Name: Hydralazine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/9/2004 Date Approved Barbeau Pharma, Inc. 790 W. Frontage Road Suite 125 Northfield IL 60093 Generic Name: Hydroxocobalamin Trade Name (if present): Cyanokit Date Designated 11/25/2003 Date Approved 12/15/2006 Designation Approved: Treatment on known or suspected cyanide poisoning Sponsor Contact Information Merck Sante, s.a.a. 37 rue Saint Romain 69008 Lyon FRANCE Generic Name: Hydroxocobalamin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/22/2000 Date Approved Jazz Pharmaceuticals 3180 Porter Drive Palo Alto CA 94304 Generic Name: Hydroxycobalamin/sodium thiosulfate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/4/1985 Date Approved Hall, Alan H., M.D. Mile 5.0 Pass Creek Road PO Box 24 Elk Mountain WY 82324 Generic Name: hydroxyurea Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/15/2005 Date Approved UPM Pharmaceuticals, Inc. 6200 Seaforth Street Baltimore MD 21224 Generic Name: Hydroxyurea Trade Name (if present): Droxia Date Designated 10/1/1990 Date Approved 2/25/1998 Designation Approved: To reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises (generally at least 3 during the preceding 12 months). Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute P.O. Box 4000 Princeton NJ 08543 Generic Name: Hypericin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/2000 Date Approved Nexell Therapeutics 2751 Centerville Rd., Suite 210 Wilmington DE 19808 Generic Name: Hypericin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/7/2000 Date Approved Nexell Therapeutics, Inc. 2751 Centerville Rd., Suite 210 Wilmington DE 19808 Generic Name: I(131)-TM-601 (chlorotoxin) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/14/2002 Date Approved TransMolecular, Inc. 840 Memorial Drive Second Floor Cambridge MA 02139 Generic Name: Iboctadekin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/3/2005 Date Approved SmithKlineBeecham Corporation d/b/a GlaxoSmithKline P. O. Box 7929 Philadelphia PA 19101 Generic Name: ibritumomab tiuxetan Trade Name (if present): Zevalin Date Designated 9/6/1994 Date Approved 2/19/2002 Designation Approved: Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin?s lymphoma, including patients with Rituximab (Rituxan?) refractory follicular non-Hodgkin?s lymphoma Sponsor Contact Information Biogen IDEC Inc. 5200 research Place San Diego CA 92122 Generic Name: Ibuprofen i.v. solution Trade Name (if present): Salprofen Date Designated 10/29/1996 Date Approved Designation Approved: Sponsor Contact Information Farmacon-IL, LLC 1720 Post Road East Suite 213 Westport CT 06880-5643 Generic Name: Ibuprofen lysine Trade Name (if present): NeoProfen Date Designated 10/29/1996 Date Approved 4/13/2006 Designation Approved: For closure of a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective Sponsor Contact Information Farmacon-IL, LLC 1720 Post Road East Suite 213 Westport CT 06880-5643 Generic Name: icatibant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/5/2004 Date Approved Jerini AG Invalidenstr, 130 10115 Berlin GERMANY Generic Name: icatibant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/25/2003 Date Approved Jerini AG Invalidenstr. 130 10115 Berlin GERMANY Generic Name: Icodextrin 7.5% with Electrolytes Peritoneal Dialysis Solution Trade Name (if present): Extraneal (with 7.5% Icodextrin) Peritoneal Dialysis Solutio Date Designated 7/18/1997 Date Approved 12/20/2002 Designation Approved: For use as a single daily exchange for the long (8-16 hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of chronic renal failure. Sponsor Contact Information Baxter Healthcare Corporation Renal Division 1620 Waukegan Road McGaw Park IL 60085 Generic Name: Idarubicin Trade Name (if present): Idamycin Date Designated 12/2/1992 Date Approved Designation Approved: Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Unit 0633-298-113 Kalamazoo MI 49001-0199 Generic Name: Idarubicin Trade Name (if present): Idamycin Date Designated 12/1/1992 Date Approved Designation Approved: Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Unit 0633-298-113 Kalamazoo MI 49001-0199 Generic Name: Idarubicin HCl for injection Trade Name (if present): Idamycin Date Designated 7/25/1988 Date Approved 9/27/1990 Designation Approved: Sponsor Contact Information Adria Laboratories, Inc. P.O. Box 16529 Columbus OH 43216 Generic Name: Idarubicin HCl for injection Trade Name (if present): Idamycin Date Designated 2/12/1991 Date Approved Designation Approved: Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Unit 0633-298-113 Kalamazoo MI 49001-0199 Generic Name: idebenone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/31/2006 Date Approved Santhera Pharmaceuticals Limited Hammerstrasse 47 SWITZERLAND Generic Name: idebenone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/16/2007 Date Approved Santhera Pharaceuticals Limited Hammerstrasse 47 SWITZERLAND Generic Name: Idebenone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/25/2004 Date Approved Santhera Pharmaceuticals LLC Hammerstrasse 25 CH-4410 Liestal SWITZERLAND Generic Name: Idoxuridine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/8/1996 Date Approved NeoPharm, Inc. 225 East Deerpath, Suite 250 Lake Forest IL 60045 Generic Name: idursulfase Trade Name (if present): Elaprase Date Designated 11/28/2001 Date Approved 7/24/2006 Designation Approved: Indicated for patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Idursulfase has been shown to improve walking capacity in these patients Sponsor Contact Information Shire Human Genetic Therapies, Inc. 700 Main Street Cambridge MA 02139 Generic Name: Ifosfamide Trade Name (if present): Ifex Date Designated 1/20/1987 Date Approved 12/30/1988 Designation Approved: In combination with certain other approved antineoplastic agents, for third line chemotherapy in the treatment of germ cell testicular cancer. Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute 5 Research Parkway, P.O. Box 5100 Wallingford CT 06492 Generic Name: Ifosfamide Trade Name (if present): Ifex Date Designated 8/7/1985 Date Approved Designation Approved: Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute P.O. Box 4000 Princeton NJ 08543-4000 Generic Name: Ifosfamide Trade Name (if present): Ifex Date Designated 8/7/1985 Date Approved Designation Approved: Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute P.O. Box 4000 Princeton NJ 08543 Generic Name: IL13-PE38QQR Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/2/2001 Date Approved NeoPharm, Inc. 150 Field Drive Suite 195 Lake Forest IL 60045 Generic Name: IL-4 Pseudomonas Toxin Fusion Protein (IL-4(38-37)-PE38KDEL) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/6/2000 Date Approved Protox Therapeutics, Inc. 1210-885 West Georgia Vancouver, British Columbia San Diego CANADA Generic Name: Iloprost inhalation solution Trade Name (if present): Ventavis Date Designated 8/17/2004 Date Approved 12/29/2004 Designation Approved: Treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms Sponsor Contact Information CoTherix, Inc. 5000 Shoreline Court South San Francisco CA 94080 Generic Name: Iloprost solution for infusion Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/21/1989 Date Approved Berlex Laboratories, Inc. 300 Fairfield Road Wayne NJ 07470 Generic Name: Iloprost solution for infusion Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/14/1990 Date Approved Berlex Laboratories, Inc. 300 Fairfield Road Wayne NJ 07470 Generic Name: Imatinib Trade Name (if present): Gleevec Date Designated 1/31/2001 Date Approved 5/10/2001 Designation Approved: Treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy Sponsor Contact Information Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover NJ 07936-1080 Generic Name: Imatinib mesylate Trade Name (if present): Gleevec Date Designated 9/9/2005 Date Approved 10/19/2006 Designation Approved: Treatment of adult patients with aggressive mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown Sponsor Contact Information Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Imatinib mesylate Trade Name (if present): Gleevec Date Designated 10/5/2005 Date Approved 10/19/2006 Designation Approved: Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements Sponsor Contact Information Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Imatinib mesylate Trade Name (if present): Gleevec Date Designated 8/25/2005 Date Approved 10/19/2006 Designation Approved: Treatment of adult patients with hypereosinophic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRÎ± fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRÎ± fusion kinase negative or unknown Sponsor Contact Information Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: imatinib mesylate Trade Name (if present): Gleevec Date Designated 10/11/2005 Date Approved 10/19/2006 Designation Approved: Treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) Sponsor Contact Information Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: imatinib mesylate Trade Name (if present): Gleevec Date Designated 12/19/2005 Date Approved 10/19/2006 Designation Approved: Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) Sponsor Contact Information Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: imatinib mesylate Trade Name (if present): Gleevec Date Designated 11/1/2001 Date Approved 2/1/2002 Designation Approved: Treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) Sponsor Contact Information Novartis Pharmaceuticals Corp. One Health Plaza East Hanover NJ 07936-1080 Generic Name: Imciromab pentetate Trade Name (if present): Myoscint Date Designated 1/25/1989 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 244 Great Valley Parkway Malvern PA 19355 Generic Name: imexon Trade Name (if present): Amplimexon Date Designated 8/12/2005 Date Approved Designation Approved: Sponsor Contact Information AmpliMed Corporation 4380 N. Campbell Ave. Tucson AZ 85718 Generic Name: Imexon Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/8/1996 Date Approved AmpliMed Corporation 2321 Camino La Zorrela Tucson AZ 85718 Generic Name: Imexon Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/1/2003 Date Approved AmpliMed Corporation 2321 Camino La Zorrela Tucson AZ 85718 Generic Name: Imexon Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/2001 Date Approved AmpliMed Corporation 2321 Camino La Zorrela Tucson AZ 85718 Generic Name: Imiglucerase Trade Name (if present): Cerezyme Date Designated 11/5/1991 Date Approved 5/23/1994 Designation Approved: Enzyme replacement therapy in patients with type I Gaucher's disease. Sponsor Contact Information Genzyme Corporation One Kendall Square Cambridge MA 02139-1562 Generic Name: Immortalized human liver cells found in the extracorporeal liver assist device Trade Name (if present): ELAD Date Designated 7/16/2004 Date Approved Designation Approved: Sponsor Contact Information Vital Therapies, Inc. 15222 Avenue of Science Suite C San Diego CA 92128 Generic Name: Immune Globulin (Human) Trade Name (if present): Gamunex Date Designated 7/27/2004 Date Approved Designation Approved: Sponsor Contact Information Talecris 8368 US 70 West Clayton NC 27520 Generic Name: Immune Globulin (Human) containing high titers of West Nile virus antibodies Trade Name (if present): Omr-IgG-am (tm) 5% (WNV) Date Designated 3/17/2004 Date Approved Designation Approved: Sponsor Contact Information OMRIX Biopharmaceuticals, Ltd. Plasma Fractionation Institute Ramat Gan 52621 ISRAEL Generic Name: Immune Globulin Intravenous (human) Trade Name (if present): Carimune NF Date Designated 5/4/2004 Date Approved Designation Approved: Sponsor Contact Information ZLB Bioplasma AG Wankdorfstrasse 10 CH-3000 Bern 22 SWITZERLAND Generic Name: Immune globulin intravenous (human) Trade Name (if present): Gammagard Liquid Date Designated 7/20/2006 Date Approved Designation Approved: Sponsor Contact Information Baxter Healthcare Corporation, Baxter Bioscience Westlake Village CA 91362 Generic Name: Immune globulin intravenous (human) Trade Name (if present): Immune Globulin Intravenous (human) Immuno, Iveegam Date Designated 11/22/1993 Date Approved Designation Approved: Sponsor Contact Information Immuno Clinical Research Corp. 750 Lexington Avenue New York NY 10022 Generic Name: Immune globulin intravenous (human) Trade Name (if present): Iveegam, Immuno Date Designated 10/13/1992 Date Approved Designation Approved: Sponsor Contact Information Immuno Clinical Research Corp. 155 East 56th Street New York NY 10022 Generic Name: Immune globulin intravenous (human) Trade Name (if present): Iveegam, Immuno Date Designated 12/16/1992 Date Approved Designation Approved: Sponsor Contact Information Immuno Clinical Research Corp. 750 Lexington Avenue, 19th Floor New York NY 10022 Generic Name: Immune globulin intravenous, human Trade Name (if present): Gamimune N Date Designated 2/18/1993 Date Approved 12/27/1993 Designation Approved: For prophylaxis of children with clinical or immunologic evidence of human immunodeficiency virus to decrease the frequency of serious and minor bacterial infections and the frequency of hospitalization, and to increase the time free of serious bacterial infections. Sponsor Contact Information Bayer Corporation Pharmaceutical Division, Biological Products 400 Morgan Lane New Haven CT 06516 Generic Name: Immune Globulin Subcutaneous (Human) Trade Name (if present): Vivaglobin P (proposed) Date Designated 9/22/2004 Date Approved Designation Approved: Sponsor Contact Information Aventis Behring, L.L.C. 1020 First Avenue P.O. Box 61501 King of Prussia PA 19406-0901 Generic Name: Implitapide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/13/2004 Date Approved Medical Research Laboratories International 2 Tesseneer Drive Highland Heights KY 41076 Generic Name: Implitapide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/19/2004 Date Approved Medical Research Laboratories International 2 Tesseneer Drive Highland Heights KY 41076 Generic Name: Imported fire ant venom, allergenic extract Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/12/1992 Date Approved ALK Laboratories, Inc. Research Center 27 Village Lane Wallingford CT 06492 Generic Name: Inalimarev and falimarev Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/10/2006 Date Approved Therion Biologics Corporation 76 Rogers Street Cambridge MA 02142 Generic Name: Indium In 111 murine monoclonal antibody FAB to myosin Trade Name (if present): Myoscint Date Designated 8/7/1989 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 244 Great Valley Parkway Malvern PA 19355 Generic Name: Indium In-111 altumomab pentetate Trade Name (if present): Hybri-ceaker Date Designated 2/6/1990 Date Approved Designation Approved: Sponsor Contact Information Hybritech, Inc. 11095 Torreyanna Road San Diego CA 92196 Generic Name: Indium-111 pentetreotide Trade Name (if present): NeuroendoMedix Date Designated 6/16/2006 Date Approved Designation Approved: Sponsor Contact Information RadioIsotope Therapy of America (RITA) Foundation 9701 Richmond Avenue Houston TX 77042 Generic Name: infliximab Trade Name (if present): Remicade Date Designated 10/23/2002 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: infliximab Trade Name (if present): Remicade Date Designated 5/6/2003 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: Infliximab Trade Name (if present): REMICADE Date Designated 11/12/2003 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: Infliximab Trade Name (if present): REMICADE Date Designated 11/12/2003 Date Approved 5/19/2006 Designation Approved: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy Sponsor Contact Information Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: Infliximab Trade Name (if present): Remicade Date Designated 5/21/2003 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: Infliximab Trade Name (if present): Remicade Date Designated 11/14/1995 Date Approved 8/24/1998 Designation Approved: Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous Sponsor Contact Information Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355-1307 Generic Name: INGN 201 Trade Name (if present): ADVEXIN Date Designated 1/27/2003 Date Approved Designation Approved: Sponsor Contact Information Introgen Therapeutics, Inc. 2250 Holcombe Blvd Houston TX 77030 Generic Name: INH-A00021 Trade Name (if present): Veronate Date Designated 6/13/2001 Date Approved Designation Approved: Sponsor Contact Information Inhibitex, Inc. 8995 Westside Parkway Suite 150 Alpharetta GA 30004 Generic Name: inolimomab Trade Name (if present): Leukotac Date Designated 10/23/2002 Date Approved Designation Approved: Sponsor Contact Information EUSA Pharma 1980 S. Easton Road Suite 250 Doylestown PA 18901 Generic Name: Inosine pranobex Trade Name (if present): Isoprinosine Date Designated 9/20/1988 Date Approved Designation Approved: Sponsor Contact Information Newport Pharmaceuticals 897 West Sixteenth Street Newport Beach CA 92663 Generic Name: Interferon alfa-2a Trade Name (if present): Roferon A Date Designated 6/6/1989 Date Approved 10/19/1995 Designation Approved: Treatment of chronic myelogenous leukemia. Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Interferon alfa-2a (recombinant) Trade Name (if present): Roferon-A Date Designated 4/18/1988 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110-1199 Generic Name: Interferon alfa-2a (recombinant) Trade Name (if present): Roferon-A Date Designated 5/11/1990 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Interferon alfa-2a (recombinant) Trade Name (if present): Roferon-A Date Designated 5/2/1990 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07119 Generic Name: Interferon alfa-2a (recombinant) Trade Name (if present): Roferon-A Date Designated 12/14/1987 Date Approved 11/21/1988 Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Interferon alfa-2a (recombinant) Trade Name (if present): Roferon-A Date Designated 5/14/1990 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110-1199 Generic Name: Interferon alfa-2a (recombinant) Trade Name (if present): Roferon-A Date Designated 10/27/1989 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110-1199 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 6/24/1987 Date Approved 11/21/1988 Designation Approved: Treatment of selected patients with AIDS-related Kaposi's sarcoma. Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 11/17/1988 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 5/13/1988 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 8/10/1988 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 4/18/1988 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 8/3/1987 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 6/22/1987 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 6/22/1987 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 8/17/1988 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-2b (recombinant) Trade Name (if present): Intron A Date Designated 5/4/1990 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Interferon alfa-nl Trade Name (if present): Wellferon Date Designated 10/16/1987 Date Approved Designation Approved: Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Interferon alfa-nl Trade Name (if present): Wellferon Date Designated 8/25/1986 Date Approved Designation Approved: Sponsor Contact Information Burroughs Wellcome Company 3030 Cornwallis Road Research Triangle Pk NC 27709 Generic Name: Interferon beta (recombinant) Trade Name (if present): R-IFN-beta Date Designated 2/12/1991 Date Approved Designation Approved: Sponsor Contact Information Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Interferon beta (recombinant) Trade Name (if present): r-HuIFN-beta Date Designated 5/9/1991 Date Approved Designation Approved: Sponsor Contact Information Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Interferon beta (recombinant) Trade Name (if present): r-HuIFN-beta Date Designated 4/18/1991 Date Approved Designation Approved: Sponsor Contact Information Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Interferon beta, recombinant human Trade Name (if present): Betaseron Date Designated 11/15/1988 Date Approved Designation Approved: Sponsor Contact Information Berlex Laboratories, Inc. 15049 San Pablo Avenue, P.O. Box 4099 Richmond CA 94804 Generic Name: Interferon beta-1a Trade Name (if present): Rebif Date Designated 3/11/1996 Date Approved Designation Approved: Sponsor Contact Information EMD Serono, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Interferon beta-1a Trade Name (if present): Avonex Date Designated 12/16/1991 Date Approved 5/17/1996 Designation Approved: Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Sponsor Contact Information Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: interferon Beta-1a Trade Name (if present): Avonex Date Designated 10/14/1998 Date Approved Designation Approved: Sponsor Contact Information Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Interferon beta-1a (recombinant human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/24/1992 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Interferon beta-1a (recombinant) Trade Name (if present): r-HuIFN-beta Date Designated 4/3/1991 Date Approved Designation Approved: Sponsor Contact Information Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Interferon beta-1a (recombinant) Trade Name (if present): Rebif Date Designated 12/2/1992 Date Approved Designation Approved: Sponsor Contact Information EMD Serono, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Interferon beta-1b Trade Name (if present): Betaseron Date Designated 11/17/1988 Date Approved 7/23/1993 Designation Approved: In ambulatory patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations. Sponsor Contact Information Chiron Corp. & Berlex Laboratories 4560 Horton Street Emeryville CA 94608 Generic Name: Interferon gamma Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/2007 Date Approved Foundation for Fatal Rare Diseases Herrengasse 21 Furstentum Liechtenstein GERMANY Generic Name: Interferon gamma 1-b Trade Name (if present): Actimmune Date Designated 9/30/1988 Date Approved 12/20/1990 Designation Approved: Sponsor Contact Information InterMune, Inc. 3280 Bayshore Blvd Brisbane CA 94005 Generic Name: Interferon gamma-1b Trade Name (if present): Actimmune Date Designated 9/30/1996 Date Approved 2/10/2000 Designation Approved: Delaying time to disease progression in patients with severe, malignant osteopetrosis. Sponsor Contact Information InterMune , Inc. 1710 Gilbreth Road, Suite 301 Burlingame CA 94010-1317 Generic Name: interferon gamma-1b Trade Name (if present): Actimmune Date Designated 9/12/2002 Date Approved Designation Approved: Sponsor Contact Information InterMune, Inc. 3280 Bayshore Boulevard Brisbane CA 94005 Generic Name: Interferon gamma-1b Trade Name (if present): Actimmune Date Designated 12/4/1995 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: Interferon-alfa-1b Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/17/2001 Date Approved Ernest C.Borden Center for Cancer Drud Discovery and Development 9500 Euclid Avenue Clevland OH 44195 Generic Name: Interleukin-1 alpha, human recombinant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/17/1991 Date Approved Immunex Corporation 51 University Street Seattle WA 98101 Generic Name: Interleukin-1 alpha, human recombinant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/17/1991 Date Approved Immunex Corporation 51 University Street Seattle WA 98101 Generic Name: Interleukin-1 receptor antagonist, human recombinant Trade Name (if present): Antril Date Designated 9/23/1991 Date Approved Designation Approved: Sponsor Contact Information Amgen, Inc. One Amgen Center Drive Thousand Oaks CA 91320-1799 Generic Name: Interleukin-1 receptor antagonist, human recombinant Trade Name (if present): Antril Date Designated 10/16/1992 Date Approved Designation Approved: Sponsor Contact Information Amgen, Inc. One Amgen Center Drive Thousand Oaks CA 91320-1799 Generic Name: Interleukin-1 Trap Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/4/2005 Date Approved Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown NY 10591 Generic Name: Interleukin-2 Trade Name (if present): Teceleukin Date Designated 5/11/1990 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Interleukin-2 Trade Name (if present): Teleleukin Date Designated 2/6/1990 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Interleukin-2 Trade Name (if present): Teceleukin Date Designated 2/5/1990 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Interleukin-2 Trade Name (if present): Teceleukin Date Designated 5/3/1990 Date Approved Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Interleukin-3 human (recombinant) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/20/1991 Date Approved Immunex Corporation 51 University Street Seattle WA 98101 Generic Name: Interleukin-3, human, recombinant Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/30/1993 Date Approved Sandoz Pharmaceuticals Corp. 59 Route 10 East Hanover NJ 07936 Generic Name: Intraoral fluoride releasing system Trade Name (if present): IFRS Date Designated 7/31/2001 Date Approved Designation Approved: Sponsor Contact Information Digestive Care, Inc. 1120 Win Drive Bethlehem PA 18017 Generic Name: Intravenous immune globulin Trade Name (if present): VitiGam Date Designated 7/26/2007 Date Approved Designation Approved: Sponsor Contact Information GammaCan Ltd. 39 Jerusalem Street ISRAEL Generic Name: Iobenguane I 123 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/1/2006 Date Approved GE Healthcare, Inc. 101 Carnegie Center Princeton NJ 08540 Generic Name: Iobenguane I 123 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/1/2006 Date Approved GE Healthcare, Inc. 101 Carnegie Center Princeton NJ 08540 Generic Name: iobenguane I 131 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/5/2007 Date Approved DraxImage Div. of Draxis Specialty Pharmaceuticals, Inc. Kirkland, Quebec H9H 4J4 CANADA Generic Name: Iobenguane I 131 Trade Name (if present): Azedra Ultratrace Date Designated 1/18/2006 Date Approved Designation Approved: Sponsor Contact Information Molecular Insight Pharmaceuticals 160 Second street Cambridge MA 02142 Generic Name: Iobenguane Sulfate I 131 Trade Name (if present): Designation Approved: Adjunctive diagnostic agent in the localization of primary or metastatic pheochromocytomas. Sponsor Contact Information Date Designated 11/14/1984 Date Approved 3/21/1990 University of Michigan UH B1 H410/0028 1500 E. Medical Center Drive Ann Arbor MI 48109-0028 Generic Name: Iobenguane Sulfate I-123 Trade Name (if present): OmaClear Date Designated 10/17/2005 Date Approved Designation Approved: Sponsor Contact Information Brogan Pharmaceuticals, LLC 312 Lacebark Street Schererville IN 46375 Generic Name: iobenguane sulfate I-123 Trade Name (if present): OmaClear Date Designated 10/21/2005 Date Approved Designation Approved: Sponsor Contact Information Brogan Pharmaceuticals, LLC 312 Lacebark Street Schererville IN 46375 Generic Name: Iodine 131 6B-iodomethyl-19-norcholesterol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/1/1984 Date Approved David E. Kuhl, M.D. University of Michigan Medical Center/1500 E. Med. B1G412 /0028 University Hospital Ann Arbor MI 48109-0028 Generic Name: Iodine I 123 murine monoclonal antibody to alpha-fetoprotein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/30/1988 Date Approved Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Iodine I 123 murine monoclonal antibody to alpha-fetoprotein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/30/1988 Date Approved Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Iodine I 123 murine monoclonal antibody to hCG Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/7/1988 Date Approved Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Iodine I 131 bis(indiumdiethylenetriaminepentaacetic acid)tyrosyllysine/hMN-14 x m734 F(ab')2 bispecific monoclonal antibody Trade Name (if present): Pentacea Date Designated 2/22/2000 Date Approved Designation Approved: Sponsor Contact Information IBC Pharmaceuticals, L.L.C. 300 American Rd. Morris Plains NJ 07950 Generic Name: Iodine I 131 Lym-1 Monoclonal Antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/2/1987 Date Approved Lederle Laboratories Division American Cyanamide Company 401 N. Middletown Road Pearl River NY 10965 Generic Name: Iodine I 131 murine monoclonal antibody IgG2a to B cell Trade Name (if present): Immurait, Ll-2-I-131 Date Designated 9/18/1989 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Iodine I 131 murine monoclonal antibody to alpha-fetoprotein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/30/1988 Date Approved Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Iodine I 131 murine monoclonal antibody to alpha-fetoprotein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/30/1988 Date Approved Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Iodine I 131 murine monoclonal antibody to hCG Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/7/1988 Date Approved Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Iodine I-131 radiolabeled chimeric MAb tumor necrosis treatment (TNT-1B) Trade Name (if present): 131IchTNT-1 Date Designated 2/12/1999 Date Approved Designation Approved: Sponsor Contact Information Peregrine Pharmaceuticals, Inc. 14282 Franklin Ave. Tustin CA 92780-7017 Generic Name: irofulven Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/27/1999 Date Approved MGI Pharma, Inc. 5775 West Old Shakoppe Rd. Suite 100 Bloomington MN 55437-3107 Generic Name: irofulven Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/6/1999 Date Approved MGI Pharma, Inc. 5775 West Old Shakoppe Rd. Suite 100 Bloomington MN 55437-3107 Generic Name: iron(III)-hexacyanoferrate(II) Trade Name (if present): Radiogardase Date Designated 5/1/2003 Date Approved 10/2/2003 Designation Approved: Treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium to increase their rates of elimination Sponsor Contact Information Heyl Chemisch-Pharmzeutische Fabrik GMBH & Co, KG Goerzallee 253 D-14167 Berlin, Federal Republic of Germany Generic Name: Isobutyramide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/25/1994 Date Approved Alpha Therapeutic Corporation 5555 Valley Boulevard Los Angeles CA 90032 Generic Name: Isobutyramide Trade Name (if present): Isobutyramide oral solution Date Designated 12/18/1992 Date Approved Designation Approved: Sponsor Contact Information Perrine, Susan P., M.D. Boston University Cancer Research Center Boston MA 02118 Generic Name: isofagomine tartrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/10/2006 Date Approved Amicus Therapeutics, Inc. 6 Cedar Brook Drive Cranbury NJ 08512 Generic Name: Japanese encephalitis vaccine (live, attenuated) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/19/1999 Date Approved Glovax Co., Ltd. Room 307, Koryo Academytel, 437-3 Ahyun-Dong, Mapo-Gu, Seoul 121-010 Generic Name: Ketoconazole Trade Name (if present): Nizoral Date Designated 3/27/1991 Date Approved Designation Approved: Sponsor Contact Information Pharmedic Company 28101 Ballard Road Lake Forest IL 60045 Generic Name: L-2-oxothiazolidine-4-carboxylic acid Trade Name (if present): Procysteine Date Designated 6/14/1994 Date Approved Designation Approved: Sponsor Contact Information Transcend Therapeutics, Inc. 640 Memorial Drive, 3rd Floor West Cambridge MA 02139 Generic Name: L-2-oxothiazolidine-4-carboxylic acid Trade Name (if present): Procysteine Date Designated 7/30/1996 Date Approved Designation Approved: Sponsor Contact Information Transcend Therapeutics, Inc. 640 Memorial Drive, 3rd Floor West Cambridge MA 02139 Generic Name: L-5-hydroxytryptophan Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/20/1999 Date Approved Watson Laboratories, Inc. 311 Bonnie Circle P.O. Box 1900 Corona CA 91718-1900 Generic Name: Lactic acid Trade Name (if present): Aphthaid Date Designated 6/29/1999 Date Approved Designation Approved: Sponsor Contact Information Frontier Pharmaceutical, Inc. SUNY Farmingdale Conklin Hall Farmingdale NY 11735 Generic Name: lactic acid bacteria (Lactobacilli, Bifidobacteria, and Steptococci) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/15/2002 Date Approved VSL Pharmaceuticals, Inc. 800 S. Frederick Avenue Gaithersburg MD 20877 Generic Name: lactic acid bacteria (Lactobacilli, Bifidobacteria, and Streptococcus species) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/15/2002 Date Approved VSL Pharmaceuticals, Inc. 800 S. Frederick Ave. Gaithersburg MD 20877 Generic Name: Lactobin Trade Name (if present): Lactobin Date Designated 9/12/1990 Date Approved Designation Approved: Sponsor Contact Information Roxane Laboratories, Inc. P.O. Box 16532 Columbus OH 43216-6532 Generic Name: L-aminocarnityl-succinyl-leucyl-argininaldiethylacetal Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/18/2006 Date Approved CepTor Corporation 200 International Circle Hunt Valley MD 21030 Generic Name: Lamotrigine Trade Name (if present): Lamictal Date Designated 8/23/1995 Date Approved 8/24/1998 Designation Approved: Adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients. Sponsor Contact Information Glaxo Wellcome Research and Development 5 Moore Drive P.O. Box 13398 Research Triangle Park NC 27709 Generic Name: Lanreotide Trade Name (if present): Somatuline Depot Date Designated 9/11/2000 Date Approved 8/30/2007 Designation Approved: Long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy Sponsor Contact Information IPSEN, Inc. 27 Maple Street Milford MA 01757 Generic Name: laronidase Trade Name (if present): Aldurazyme Date Designated 9/24/1997 Date Approved 4/30/2003 Designation Approved: Treatment for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms Sponsor Contact Information BioMarin Pharmaceutical, Inc. 371 Bel Marin Keys Boulevard, Suite 210 Novato CA 94949-5608 Generic Name: Latrodectus immune F(ab)2 Trade Name (if present): Aracmyn Date Designated 6/18/2001 Date Approved Designation Approved: Sponsor Contact Information Rare Disease Therapeutics, Inc. 1101 Kermit Drive, Suite 608 Nashville TN 37217 Generic Name: L-Baclofen Trade Name (if present): Neuralgon Date Designated 1/30/1992 Date Approved Designation Approved: Sponsor Contact Information Pharmascience Inc. 6111 Royalmount, Suite 100 Montreal, Quebec H4P 2T4 CANADA Generic Name: L-baclofen Trade Name (if present): Neuralgon Date Designated 12/17/1991 Date Approved Designation Approved: Sponsor Contact Information Pharmascience Inc. 6111 Royalmount, Suite 100 Montreal, Quebec H4P 2T4 CANADA Generic Name: L-Baclofen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/6/1998 Date Approved Pharmascience Inc. 6111 Royalmount, #100 Montreal, Quebec H4P 2T4 CANADA Generic Name: L-baclofen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/13/1990 Date Approved Fromm, Gerhard M.D. University Of Pittsburgh School of Medicine Pittsburgh PA 15261 Generic Name: L-cycloserine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/1/1989 Date Approved Lev, Meir M.D. The City College, City University Of NY Medical Sc Convent Avenue at 138 Street New York NY 10031 Generic Name: L-cysteine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/16/1994 Date Approved Brigham and Women's Hospital Channing Laboratory Dept. of Medicine Boston MA 02115 Generic Name: Leflunomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/18/1996 Date Approved Williams, MD, James W. Rush-Presbyterian-St. Luke's Medical Ctr., Dept. o 1653 West Congress Parkway Chicago IL 60612-3833 Generic Name: lenalidomide Trade Name (if present): Revlimid Date Designated 1/29/2004 Date Approved 12/27/2005 Designation Approved: Treatment of patients with transfusion dependant anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities Sponsor Contact Information Celgene Corporation 86 Morris Avenue Summit NJ 07901 Generic Name: lenalidomide Trade Name (if present): Revlimid Date Designated 1/17/2007 Date Approved Designation Approved: Sponsor Contact Information Celgene Corporation 86 Morris Avenue Summit NJ 07901 Generic Name: lenalidomide Trade Name (if present): Revlimid Date Designated 9/20/2001 Date Approved 6/29/2006 Designation Approved: For use in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. Sponsor Contact Information Celgene Corporation 86 Morris Avenue Summit NJ 07901 Generic Name: Lentiviral vector encoded with a human beta-globin gene plasmid Trade Name (if present): Thalagen Date Designated 1/11/2006 Date Approved Designation Approved: Sponsor Contact Information Errant Gene Therapeutics, LLC 200 West Jackson Blvd. Chicago IL 60606 Generic Name: Lepirudin Trade Name (if present): Refluden Date Designated 2/13/1997 Date Approved 3/6/1998 Designation Approved: For anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease in order to prevent further thromboembolic complications. Sponsor Contact Information Hoechst Marion Roussel Frankfurt am Main P.O. Box 1140 Marburg GERMANY Generic Name: Lestaurtinib Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/24/2006 Date Approved Cephalon, Inc. 41 Moores Road Frazer PA 19355 Generic Name: Leucovorin Trade Name (if present): Leucovorin calcium Date Designated 12/8/1986 Date Approved 12/12/1991 Designation Approved: For use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Sponsor Contact Information Immunex Corporation 51 University Street Seattle WA 98101 Generic Name: Leucovorin Trade Name (if present): Leucovorin calcium Date Designated 8/17/1988 Date Approved 8/31/1988 Designation Approved: Sponsor Contact Information Immunex Corporation 51 University Street Seattle WA 98101 Generic Name: Leucovorin calcium Trade Name (if present): Wellcovorin Date Designated 6/23/1988 Date Approved Designation Approved: Sponsor Contact Information Glaxo Wellcome Research and Development 5 Moore Drive PO Box 13398 Research Triangle Park NC 27709 Generic Name: leukocyte interlukin Trade Name (if present): Multikine Date Designated 5/4/2007 Date Approved Designation Approved: Sponsor Contact Information CEL-SCI Corporation 8229 Boone Blvd. Suite 802 Vienna VA 22182 Generic Name: Leupeptin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/18/1990 Date Approved Neuromuscular Adjuncts, Inc. S.U.N.Y. at Stony Brook H.S.C. T18-020 Stony Brook NY 11794-8181 Generic Name: Leuprolide acetate Trade Name (if present): Lupron Injection Date Designated 7/25/1988 Date Approved 4/16/1993 Designation Approved: Treatment of children with central precocious puberty. Sponsor Contact Information Tap Pharmaceuticals, Inc. 2355 Waukegan Road Deerfield IL 60015 Generic Name: Levocabastine HCl ophthalmic suspension 0.05% Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/29/1988 Date Approved Iolab Pharmaceuticals 500 Iolab Drive Claremont CA 94608 Generic Name: Levocarnitine Trade Name (if present): Carnitor Date Designated 9/6/1988 Date Approved 12/15/1999 Designation Approved: Prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue, Suite 300 Gaithersburg MD 20877 Generic Name: Levocarnitine Trade Name (if present): Carnitor Date Designated 11/24/1986 Date Approved Designation Approved: Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Levocarnitine Trade Name (if present): Carnitor Date Designated 11/15/1989 Date Approved Designation Approved: Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Levocarnitine Trade Name (if present): Carnitor Date Designated 11/15/1989 Date Approved Designation Approved: Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Levocarnitine Trade Name (if present): Carnitor Date Designated 4/7/1997 Date Approved Designation Approved: Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 S. Frederick Avenue, Suite 300 Gaithersburg MD 20877 Generic Name: Levocarnitine Trade Name (if present): Carnitor Date Designated 11/22/1993 Date Approved Designation Approved: Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Levocarnitine Trade Name (if present): Carnitor Date Designated 7/26/1984 Date Approved 12/16/1992 Designation Approved: Treatment of primary systemic carnitine deficiency. (approved 12/27/85) Treatment of secondary carnitine deficiency. (approved 12/16/92) Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Levocarnitine Trade Name (if present): Carnitor Date Designated 2/28/1984 Date Approved 4/10/1986 Designation Approved: Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Levodopa and carbidopa Trade Name (if present): Duodopa Date Designated 1/18/2000 Date Approved Designation Approved: Sponsor Contact Information Solvay Pharmaceuticals, Inc. 901 Sawyer Road Marietta GA 30062 Generic Name: Levofloxacin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/27/2008 Date Approved Mpex Pharmaceuticals, Inc. 11535 Sorrento Valley Road San Diego CA 92121 Generic Name: Levoleucovorin Trade Name (if present): Date Designated 8/1/1991 Date Approved 3/7/2008 Designation Approved: Levoleucovorin rescue is indicated after high-dose methotrexate therapy in osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists Sponsor Contact Information Spectrum Pharmaceuticals, Inc. 157 Technology Drive Irgine CA 92618 Generic Name: Levomethadyl acetate hydrochloride Trade Name (if present): Orlaam Date Designated 1/24/1985 Date Approved 7/9/1993 Designation Approved: For the management of opiate dependence. Sponsor Contact Information Biodevelopment Corporation 8180 Greensboro Drive, Suite 1000 McLean VA 22102 Generic Name: L-glutamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/1/2001 Date Approved Emmaus Medical, Inc. 3870 Del Amo Blvd Unit 507 Torrance CA 90503-7701 Generic Name: L-glutamyl-L-tryptophan Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/20/1999 Date Approved Implicit Bioscience Pty Ltd P. O. Box 2072. Toowong Business Center AUSTRALIA Generic Name: liarozole Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/18/2004 Date Approved Barrier Therapeutics, Inc 600 College Road East Princeton NJ 08540 Generic Name: Lidocaine patch 5% Trade Name (if present): Lidoderm Patch Date Designated 10/24/1995 Date Approved 3/19/1999 Designation Approved: Sponsor Contact Information Teikoku Pharma USA, Inc. 745-D Camden Ave. Campbell CA 95008-4146 Generic Name: Lintuzumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/20/2007 Date Approved Seattle Genetics, Inc. 21823 30th Drive Southeast Bothell WA 98021 Generic Name: lintuzumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/30/2007 Date Approved Seattle Genetics, Inc. 21823 30th Drive Southeast Bothell WA 98021 Generic Name: lintuzumab Trade Name (if present): Zamyl Date Designated 9/9/2002 Date Approved Designation Approved: Sponsor Contact Information Protein Design Labs, Inc. 34801 Campus Drive Fremont CA 94555 Generic Name: Liothyronine sodium injection Trade Name (if present): Triostat Date Designated 7/30/1990 Date Approved 12/31/1991 Designation Approved: Treatment of myxedema coma/precoma. Sponsor Contact Information SmithKline Beecham Pharmaceuticals One Franklin Plaza P.O. Box 7929 Philadelphia PA 19101 Generic Name: Lipid/DNA human cystic fibrosis gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/8/1996 Date Approved Genzyme Corporation Metrowest Place P.O. Box 9322 Framingham MA 01701-9322 Generic Name: Liposomal amphotericin B Trade Name (if present): AmBisome Date Designated 12/10/1996 Date Approved Designation Approved: Sponsor Contact Information Fujisawa USA, Inc. 3 Parkway North Center Deerfield IL 60015 Generic Name: Liposomal amphotericin B Trade Name (if present): AmBisome Date Designated 12/6/1996 Date Approved 8/11/1997 Designation Approved: Treatment of visceral leishmaniasis. Sponsor Contact Information Fujisawa USA, Inc. 3 Parkway North Center Deerfield IL 60015 Generic Name: Liposomal amphotericin B Trade Name (if present): AmBisome Date Designated 12/10/1996 Date Approved 8/11/1997 Designation Approved: Treatment of disseminated cryptococcosis including meningitis. Sponsor Contact Information Fujisawa USA, Inc. 3 Parkway North Center Deerfield IL 60015 Generic Name: Liposomal annamycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/17/2005 Date Approved Callisto Pharmaceuticals, Inc. 420 Lexington Avenue New York NY 10170 Generic Name: Liposomal annamycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/17/2005 Date Approved Callisto Pharmaceuticals, Inc. 420 Lexington Avenue New York NY 10170 Generic Name: Liposomal ciprofloxacin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/27/2006 Date Approved Aradigm Corporation 3929 Point Eden Way Hayward CA 94545 Generic Name: Liposomal ciprofloxacin for inhalation Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/19/2006 Date Approved Aradigm Corporation 3929 Point Eden Way Hayward CA 94545 Generic Name: Liposomal cisplatin Trade Name (if present): LipOva-Pt Date Designated 5/23/2006 Date Approved Designation Approved: Sponsor Contact Information Transave, Inc. 11 Deer Park Drive Monmouth Junction NJ 08852-1923 Generic Name: Liposomal cyclosporin A Trade Name (if present): Cyclospire Date Designated 4/30/1998 Date Approved Designation Approved: Sponsor Contact Information Vernon Knight, M.D. Baylor College of Medicine, Dept. of Molecular Phy One Baylor Plaza Houston TX 77030 Generic Name: Liposomal doxorubicin hydrochloride Trade Name (if present): Sarcodoxome Date Designated 12/27/2006 Date Approved Designation Approved: Sponsor Contact Information GP-Pharm SA Pol. Ind. Els Vinyets els Fogars n 2, Quinti de Mediona Barcelona SPAIN Generic Name: Liposomal N-Acetylglucosminyl-NAcetylmuramly-L-Ala-D-isoGln-L-Ala gylcerolidpalmitoyl Trade Name (if present): ImmTher Date Designated 6/10/1998 Date Approved Designation Approved: Sponsor Contact Information Endorex Corp. 900 North Shore Drive Lake Bluff IL 60044 Generic Name: Liposomal N-Acetylglucosminyl-NAcetylmuramly-L-Ala-D-isoGln-L-Ala gylcerolidpalmitoyl Trade Name (if present): ImmTher Date Designated 6/10/1998 Date Approved Designation Approved: Sponsor Contact Information Endorex Corp. 900 North Shore Drive Lake Bluff IL 60044 Generic Name: Liposomal nystatin Trade Name (if present): Nyotran Date Designated 6/13/2000 Date Approved Designation Approved: Sponsor Contact Information The University of Texas M.D. Anderson Cancer Center Unit 038 Houston TX 77030 Generic Name: liposomal p-ethoxy growth receptor bound protein-2 antisense product Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/5/2003 Date Approved Bio-Path, Inc. 3293 Harrison Blvd., Suite 230 Ogden UT 84403 Generic Name: Liposomal prostaglandin E1 injection Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/25/1996 Date Approved Liposome Company, Inc. One Research Way Princeton NJ 08540 Generic Name: Liposomal-cis-bis-neodecanoato-trans-R,R1,2-diaminocyclohexane-Pt (II) Trade Name (if present): Aroplatin Date Designated 9/1/1999 Date Approved Designation Approved: Sponsor Contact Information Antigenics Incorporated 3 Forbes Road Lexington MA 02421 Generic Name: Liposome encapsulated recombinant interleukin-2 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/25/1991 Date Approved Biomira, Inc. 2011 - 94th Street Edmonston, AB CANADA Generic Name: Liposome encapsulated recombinant interleukin-2 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/20/1994 Date Approved Oncothyreon Canada, Inc. 2011 - 94th Street NW Edmonton CANADA Generic Name: Lisofylline Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/10/1999 Date Approved Cell Therapeutics, Inc. 201 Elliot Avenue West201 Suite 400 Seattle WA 98119 Generic Name: L-leucovorin Trade Name (if present): Isovorin Date Designated 12/18/1990 Date Approved Designation Approved: Sponsor Contact Information Spectrum Pharmaceuticals, Inc. 157 Technology Drive Irvine CA 92618 Generic Name: Lodoxamide tromethamine Trade Name (if present): Alomide Ophthalmic Solution Date Designated 10/16/1991 Date Approved 9/23/1993 Designation Approved: Treatment of ocular disorders referred to by the terms vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis. Sponsor Contact Information Alcon Laboratories, Inc. 6201 South Freeway Fort Worth TX 76134 Generic Name: Loxoribine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/24/1992 Date Approved R. W. Johnson Pharmaceutical Research Institute Route 202, P.O. Box 300 Raritan NJ 08869 Generic Name: L-threonine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/24/1992 Date Approved Interneuron Pharmaceuticals, Inc. 99 Hayden Ave., Suite 200 Lexington MA 02421-7966 Generic Name: L-threonine Trade Name (if present): Threostat Date Designated 2/6/1989 Date Approved Designation Approved: Sponsor Contact Information Tyson And Associates 12832 Chadron Avenue Hawthorne CA 90250 Generic Name: L-threonyl-L-prolyl-L-prolyl-L-threonine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/26/2005 Date Approved Nyxis Neurotherapies, Inc. 1801 Maple Avenue Suite 4300 Evanston IL 60201 Generic Name: L-tyrosine-L-serine-L-leucine Trade Name (if present): CMS-024 Date Designated 9/10/2004 Date Approved Designation Approved: Sponsor Contact Information CMS Peptides Patent Holding Company Limited Unit 2106, 21st Floor, Island Place Tower 510 King's Rd North Point HONG KONG Generic Name: Lucinactant Trade Name (if present): Surfaxin Date Designated 5/23/2006 Date Approved Designation Approved: Sponsor Contact Information Discovery Laboratories, Inc 2600 Kelly Road Warrington PA 18976 Generic Name: Lucinactant Trade Name (if present): Surfaxin Date Designated 10/21/2005 Date Approved Designation Approved: Sponsor Contact Information Discovery Labsoratories, Inc. 2600 Kelly Road Warrington PA 18976 Generic Name: Lucinactant Trade Name (if present): Surfaxin Date Designated 7/30/1996 Date Approved Designation Approved: Sponsor Contact Information Discovery Laboratories, Inc. 2600 Kelly Road Warrington PA 18976 Generic Name: Lucinactant Trade Name (if present): Surfaxin Date Designated 7/17/1995 Date Approved Designation Approved: Sponsor Contact Information Discovery Laboratories, Inc. 2600 Kelly Road Warrington PA 18976 Generic Name: Lucinactant Trade Name (if present): Surfaxin Date Designated 10/18/1995 Date Approved Designation Approved: Sponsor Contact Information Discovery Laboratories, Inc. 2600 Kelly Road Warrington PA 18976 Generic Name: Lysine acetylsalicylate injectable Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/1/1989 Date Approved G.D. Searle & Company 4901 Searle Parkway Skokie IL 60077 Generic Name: Mafenide acetate solution Trade Name (if present): Sulfamylon solution Date Designated 7/18/1990 Date Approved 6/5/1998 Designation Approved: Sponsor Contact Information Mylan Laboratories, Inc. 781 Chestnut Ridge Road P.O. Box 4310 Morgantown WV 26504-4310 Generic Name: Mafosfamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/21/2003 Date Approved Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake IL 60073-0490 Generic Name: Mammalian target of rapamcyin (mTOR) inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/12/2005 Date Approved ARIAD Pharmaceuticals, Inc 26 Landsdowne Street Cambridge MA 02139-4234 Generic Name: Manganese superoxide dismutase mimetic Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/27/2008 Date Approved ActivBiotics, Inc. 110 Hartwell Avenue Lexington MA 02421 Generic Name: Mannitol Trade Name (if present): Bronchitol Date Designated 2/11/2005 Date Approved Designation Approved: Sponsor Contact Information Pharmaxis Ltd. 10 Rodborough Rd. NSW 2086 AUSTRALIA Generic Name: mannopentaose phosphate sulfate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/27/2004 Date Approved Progen Industries Limited P. O. Box 28 Richlands 4077 AUSTRALIA Generic Name: maribavir Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/2007 Date Approved ViroPharma Inc. 397 Eagleview Blvd. Exton PA 19341 Generic Name: Marijuana Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/25/1999 Date Approved Multidisciplinary Association for Psychedelic Studies, Inc. 3 Francis St. Belmont MA 02478 Generic Name: Matrix metalloproteinase inhibitor Trade Name (if present): Galardin Date Designated 12/5/1991 Date Approved Designation Approved: Sponsor Contact Information Glycomed, Inc 860 Atlantic Avenue Alameda CA 94501 Generic Name: MaxAdFVIII Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/3/2003 Date Approved GenStar Therapeutics Corporation 10865 Altman Row Suite 200 San Diego CA 92121-1113 Generic Name: Mazindol Trade Name (if present): Sanorex Date Designated 12/8/1986 Date Approved Designation Approved: Sponsor Contact Information Collipp, Platon J. M.D. 176 Memorial Drive Jesup GA 31545 Generic Name: Mecamylamine Trade Name (if present): Inversine Date Designated 10/14/1998 Date Approved Designation Approved: Sponsor Contact Information Targacept, Inc. 200 East First St. Suite 300 Winston-Salem NC 27101-4165 Generic Name: mecasermin Trade Name (if present): Iplex Date Designated 12/3/2007 Date Approved Designation Approved: Sponsor Contact Information Insmed, Inc. 8720 Stony Point Parkway Richmond VA 23235 Generic Name: Mecasermin Trade Name (if present): Myotrophin Date Designated 8/5/1991 Date Approved Designation Approved: Sponsor Contact Information Cephalon, Inc. 41 Moores Road P. O. Box 4011 Frazer PA 19355 Generic Name: Mecasermin Trade Name (if present): Increlex Date Designated 12/12/1995 Date Approved 8/30/2005 Designation Approved: Long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone. Sponsor Contact Information Tercica, Inc. 2000 Sierra Point Parkway Suite 400 Brisbane CA 94005 Generic Name: mecasermin rinfabate Trade Name (if present): iPLEX Date Designated 5/17/2002 Date Approved 12/12/2005 Designation Approved: Treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone Sponsor Contact Information Insmed, Inc. 8720 Stony Point Parkway Suite 200 Richmond VA 23235 Generic Name: meclorethamine or nitrogen mustard Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/12/2004 Date Approved Yaupon Therapeutics, Inc. 259 Radnor Chester Road Radnor PA 19087 Generic Name: MEDI-522 Trade Name (if present): Vitaxin Date Designated 4/14/2004 Date Approved Designation Approved: Sponsor Contact Information MedImmune, LLC One MedImmune Way Gaithersburg MD 20878 Generic Name: Medroxyprogesterone acetate Trade Name (if present): Hematrol Date Designated 2/22/2001 Date Approved Designation Approved: Sponsor Contact Information InKine Pharmaceutical Company, Inc. 1787 Sentry Parkway West Building 18, Suite 440 Blue Bell PA 19422 Generic Name: Mefloquine HCl Trade Name (if present): Mephaquin Date Designated 7/22/1987 Date Approved Designation Approved: Sponsor Contact Information Mepha AG 4143 Dornach POSTFASH 137 SWITZERLAND Generic Name: Mefloquine HCl Trade Name (if present): Mephaquin Date Designated 7/22/1987 Date Approved Designation Approved: Sponsor Contact Information Mepha AG 4143 Dornach POSTFASH 137 SWITZERLAND Generic Name: Mefloquine HCl Trade Name (if present): Lariam Date Designated 4/13/1988 Date Approved 5/2/1989 Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Mefloquine HCl Trade Name (if present): Lariam Date Designated 4/13/1988 Date Approved 5/2/1989 Designation Approved: Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Megestrol acetate Trade Name (if present): Megace Date Designated 4/13/1988 Date Approved 9/10/1993 Designation Approved: Treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immune deficiency syndrome. Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute 2400 West Lloyd Expressway Evansville IN 47721 Generic Name: Melanoma autologous dendritic cell vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/6/2006 Date Approved Hoag Memorial Hospital Presbyterian Hoag Cancer Center Cell Biology Laboratory Building 41 Newport Beach CA 92658 Generic Name: Melanoma cell vaccine Trade Name (if present): Canvaxin Date Designated 10/13/1994 Date Approved Designation Approved: Sponsor Contact Information CancerVax Corporation 2110 Rutherford Road Carlsbad CA 92008 Generic Name: Melanoma peptide vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/29/2005 Date Approved Bristol-Myers Squibb Research Inst 5 Research Parkway P. O. Box 5100 Wallingford CT 06492 Generic Name: Melanoma vaccine Trade Name (if present): Melacine Date Designated 12/20/1989 Date Approved Designation Approved: Sponsor Contact Information Ribi ImmunoChem Research, Inc. 533 Old Corvallis Road Hamilton MT 59840 Generic Name: Melatonin Trade Name (if present): Circadin Date Designated 7/9/2004 Date Approved Designation Approved: Sponsor Contact Information Neurim Pharmaceuticals, Ltd. 8 Hanechoshet St. Tel-Aviv ISRAEL Generic Name: Melatonin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/15/1993 Date Approved Sack, Robert, M.D. Oregon Health Sciences University 3181 S.W. Sam Jackson Park Road Portland OR 97201 Generic Name: meloxicam Trade Name (if present): Mobic Date Designated 11/22/2002 Date Approved 8/11/2005 Designation Approved: For relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age or older Sponsor Contact Information Boehringer Ingelheim Pharmaceuticals, Inc. 900 Ridgebury Road P. O. Box 368 Ridgefield CT 06877-0368 Generic Name: Melphalan Trade Name (if present): Alkeran for Injection Date Designated 3/3/1992 Date Approved Designation Approved: Sponsor Contact Information Glaxo Wellcome Research and Development 5 Moore Drive PO Box 13398 Research Triangle Park NC 27709 Generic Name: Melphalan Trade Name (if present): Alkeran For Injection Date Designated 2/24/1992 Date Approved 11/18/1992 Designation Approved: For the palliative treatment of patients with multiple myeloma for whom oral melphalan is not appropriate. Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: mepivacaine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/8/2007 Date Approved Cinergen, LLC 146 Medinah Drive Blue Bell PA 19422-3212 Generic Name: Mepivacaine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/18/2006 Date Approved Cinergen 146 Medinah Drive Blue Bell PA 19422-3212 Generic Name: mepolizumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/28/2004 Date Approved GlaxoSmithKline Pharmaceuticals P.O. Box 7929 Philadelphia PA 19101 Generic Name: Meropenem Trade Name (if present): Merrem IV Date Designated 4/27/2000 Date Approved Designation Approved: Sponsor Contact Information AstraZeneca Pharmaceuticals 1800 Concord Pike PO Box 15437 Wilmington DE 19850-5437 Generic Name: mesalamine; 5-aminosalicylic acid Trade Name (if present): Lialda Date Designated 2/27/2008 Date Approved Designation Approved: Sponsor Contact Information Shire 725 Chesterbrook Blvd. Wayne PA 19087-5637 Generic Name: Mesna Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/16/1987 Date Approved Asta Medica , Inc. 890 East St. Tewksbury MA 01876-1496 Generic Name: Mesna Trade Name (if present): Mesnex Date Designated 11/14/1985 Date Approved 12/30/1988 Designation Approved: Sponsor Contact Information Degussa Corporation 65 Challenger Road Ridgefield Park NJ 07660 Generic Name: Methionine/L-methionine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/21/1996 Date Approved Genopia USA, Inc. 90 Gold Street, 6N New York NY 10038 Generic Name: methotrexate Trade Name (if present): Rheumatrex Date Designated 8/23/1993 Date Approved Designation Approved: Sponsor Contact Information Wyeth-Ayerst Laboratories P.O. Box 8299 Philadelphia PA 19101-8299 Generic Name: Methotrexate sodium Trade Name (if present): Methotrexate Date Designated 10/21/1985 Date Approved 4/7/1988 Designation Approved: For the use of high dose methotrexate with leucovorin rescue in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor. Sponsor Contact Information Lederle Laboratories Division of American Cyanamid Company 401 N. Middletown Road Pearl River NY 10965 Generic Name: Methotrexate with laurocapram Trade Name (if present): Methotrexate/azone Date Designated 10/15/1990 Date Approved Designation Approved: Sponsor Contact Information Echo Therapeutics, Ltd. 10 Forge Parkway Franklin MA 02038 Generic Name: Methoxsalen Trade Name (if present): Uvadex Date Designated 10/14/1998 Date Approved Designation Approved: Sponsor Contact Information Therakos, Inc. 437 Creamery Way Exton PA 19431 Generic Name: metreleptin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/22/2001 Date Approved Amylin Pharmaceuticals, Inc. 9360 Towne Centre Drive San Diego CA 92121 Generic Name: metreleptin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/22/2001 Date Approved Amylin Pharmaceuticals, Inc. 9360 Towne Center Drive San Diego CA 92121 Generic Name: Metronidazole Trade Name (if present): Metrogel Date Designated 10/24/1991 Date Approved Designation Approved: Sponsor Contact Information Galderma Laboratories, Inc. P.O. Box 331329 Fort Worth TX 76163 Generic Name: Metronidazole (topical) Trade Name (if present): Flagyl Date Designated 11/24/1987 Date Approved Designation Approved: Sponsor Contact Information Searle 4901 Searle Parkway Skokie IL 60077 Generic Name: Metronidazole (topical) Trade Name (if present): Metrogel Date Designated 10/22/1987 Date Approved 11/22/1988 Designation Approved: Sponsor Contact Information Galderma Laboratories, Inc. P.O. Box 331329 Fort Worth TX 76163 Generic Name: Metronidazole 10% ointment Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/8/2007 Date Approved S.L.A. Pharma (UK) Ltd Elite House Leavesden Watford WD25 7SA UNITED KINGDOM Generic Name: Mibefradil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/15/2007 Date Approved Tau Therapeutics, LLC 2988 Cove Trace Charlottesville VA 22911 Generic Name: Microbubble contrast agent Trade Name (if present): Filmix Neurosonographic Contrast Agent Date Designated 11/16/1990 Date Approved Designation Approved: Sponsor Contact Information Cav-Con, Inc. 55 Knollwood Road Farmington CT 06032 Generic Name: Microvesiculated modified glycosylated tissue factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/2007 Date Approved Thrombotargets Corp. 2530 Meridian Parkway Durham NC 27713 Generic Name: Microvesiculated modified glycosylated tissue factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/25/2007 Date Approved Thrombotargets Corp. 2530 Meridian Parkway Suite 3023 Durham NC 27713 Generic Name: Midazolam HCl Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/8/2006 Date Approved Schwarz Biosciences, Inc. 8010 Arco Corporate Drive Raleigh NC 27617 Generic Name: Midodrine HCl Trade Name (if present): Amatine Date Designated 12/5/1996 Date Approved 9/6/1996 Designation Approved: Treatment of symptomatic orthostatic hypotension. Sponsor Contact Information Schier Ridgewood Meridian Center III 6 Industrial Way West Eatontown NJ 07724 F.K.A. (Roberts Pharmaceutical Corp.) Generic Name: mifamuritide Trade Name (if present): Junovan Date Designated 6/5/2001 Date Approved Designation Approved: Sponsor Contact Information Immuno-Designed Molecules 9 Parker Irvine CA 92618-1605 Generic Name: Mifepristone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/7/2005 Date Approved HRA Pharma 19, rue Frederick Lmaitre 75020 Paris FRANCE Generic Name: mifepristone Trade Name (if present): Corlux Date Designated 7/5/2007 Date Approved Designation Approved: Sponsor Contact Information Corcept Therapeutics, Inc. 149 Commonwealth Drive Menlo Park CA 94025 Generic Name: miglustat Trade Name (if present): Zavesca Date Designated 5/29/1998 Date Approved 7/31/2003 Designation Approved: Treatment of mild to moderate Type I Gaucher disease in adults for whom enzyme replacement therapy is not a therapeutic option (e.g., due to constraints such as allergy, hypersensitivity, or poor venous access). Sponsor Contact Information Actelion Pharmaceuticals Ltd Gewerbestrasse 16 CH - 4123 Allschwi SWITZERLAND Generic Name: milatuzumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/10/2008 Date Approved Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: miltefosine Trade Name (if present): Impavido Date Designated 10/10/2006 Date Approved Designation Approved: Sponsor Contact Information Zentaris GmbH Weismullerstrasse 50 GERMANY Generic Name: Minocycline HCl Trade Name (if present): Minocin Intravenous Date Designated 6/19/1992 Date Approved Designation Approved: Sponsor Contact Information Lederle Laboratories Division Division of American Cyanamid Company 401 N. Middletown Road Pearl River NY 10965 Generic Name: Minocycline hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/28/2006 Date Approved Autoimmunity Research Foundation Autoimmunity Research, Inc. Thousand Oaks CA 91360 Generic Name: misoprostol Trade Name (if present): GyMiso Date Designated 1/10/2005 Date Approved Designation Approved: Sponsor Contact Information Gynuity Health Projects, LLC 15 East 26th Street New York NY 10010 Generic Name: Mitoguazone Trade Name (if present): apep Date Designated 3/18/1994 Date Approved Designation Approved: Sponsor Contact Information ILEX Oncology, Inc. 4545 Horizon Hill Blvd. San Antonio TX 78229-2263 Generic Name: Mitolactol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/23/1989 Date Approved Biopharmaceutics, Inc. 990 Station Road Bellport NY 11713 Generic Name: Mitolactol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/12/1995 Date Approved Biopharmaceutics, Inc. 990 Station Road Bellport NY 11713 Generic Name: mitomycin-C Trade Name (if present): Trabomycin Date Designated 1/8/2008 Date Approved Designation Approved: Sponsor Contact Information Mobius Therapeutics, Inc. 743 Spirit 40 Park Drive Chesterfield MO 63005 Generic Name: Mitomycin-C Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/20/1993 Date Approved IOP Inc. 3100 Airway Avenue, Suite 106 Costa Mesa CA 92626 Generic Name: Mitoxantrone Trade Name (if present): Novantrone Date Designated 8/21/1996 Date Approved 11/13/1996 Designation Approved: In combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. Sponsor Contact Information Serono One Technology Place Rockland MA 02370 Generic Name: Mitoxantrone Trade Name (if present): Novantrone Date Designated 8/13/1999 Date Approved 10/13/2000 Designation Approved: Reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly adnormal between relapses). Sponsor Contact Information Serono, Inc. One Technoloogy Place Rockland MA 02370 Generic Name: Mitoxantrone Trade Name (if present): Novantrone Date Designated 8/13/1999 Date Approved 10/13/2000 Designation Approved: Reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly adnormal between relapses). Sponsor Contact Information Serono, Inc. One Technology Place Rockland MA 02370 Generic Name: Mitoxantrone HCl Trade Name (if present): Novantrone Date Designated 7/13/1987 Date Approved 12/23/1987 Designation Approved: Sponsor Contact Information Lederle Laboratories Division of American Cyanamid Company 401 N. Middletown Road Pearl River NY 10965 Generic Name: MN14 monoclonal antibody to carcinoembryonic antigen Trade Name (if present): Cea-Cide Date Designated 9/18/1998 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Rd. Morris Plains NJ 07950 Generic Name: MN14 monoclonal antibody to carcinoembryonic antigen Trade Name (if present): Cea-Cide Date Designated 11/24/1998 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Modafinil Trade Name (if present): Provigil Date Designated 3/15/1993 Date Approved 12/24/1998 Designation Approved: Improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. Sponsor Contact Information Cephalon, Inc. 145 Brandywine Parkway West Chester PA 19380 Generic Name: Molgramostim Trade Name (if present): Leucomax Date Designated 1/24/1989 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Molgramostim Trade Name (if present): Leucomax Date Designated 9/25/1989 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: monarsen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/14/2003 Date Approved Medica Venture Partners Ackerstein Towers, Bldg B, 10th Floor ISRAEL ISRAEL Generic Name: Monoclonal Ab(murine) anti-idiotype melanoma-associated antigen Trade Name (if present): Melimmune Date Designated 9/19/1994 Date Approved Designation Approved: Sponsor Contact Information IDEC Pharmaceuticals Corporation 3030 Callan Road San Diego CA 92121 Generic Name: Monoclonal antibodies (murine or human) to B-cell lymphoma Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/6/1986 Date Approved IDEC Pharmaceuticals Corporation 11011 Torreyana Road San Diego CA 92121 Generic Name: Monoclonal antibody 17-1a Trade Name (if present): Panorex Date Designated 4/4/1988 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 244 Great Valley Parkway Malvern PA 19355 Generic Name: Monoclonal antibody for immunization against lupus nephritis Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/7/1993 Date Approved VivoRx Autoimmune, Inc. 2825 Santa Monica Blvd., Suite 200 Santa Monica CA 90404 Generic Name: Monoclonal antibody to cytomegalovirus (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/15/1991 Date Approved Protein Design Labs, Inc. 2375 Garcia Avenue Mountain View CA 94043 Generic Name: Monoclonal antibody to cytomegalovirus (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/13/1991 Date Approved Protein Design Labs, Inc. 2375 Garcia Avenue Mountain View CA 94043 Generic Name: Monoclonal antibody to hepatitis B virus (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/17/1991 Date Approved Protein Design Labs, Inc. 34801 Campus Dr. Fremont CA 94555 Generic Name: Monoclonal antibody-B43.13 Trade Name (if present): Ovarex MAb-B43.13 Date Designated 11/25/1996 Date Approved Designation Approved: Sponsor Contact Information Unither Pharmaceuticals. Inc. 15 Walnut Street Suite 300 Wellesley Hills MA 02481 Generic Name: Monoclonal antiendotoxin antibody XMMEn0e5 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/4/1985 Date Approved Pfizer, Inc. 235 East 42nd Street New York NY 10017 Generic Name: Monolaurin Trade Name (if present): Glylorin Date Designated 4/29/1993 Date Approved Designation Approved: Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive PO Box 13398 Research Triangle Park NC 27709 Generic Name: Monooctanoin Trade Name (if present): Moctanin Date Designated 5/30/1984 Date Approved 10/31/1985 Designation Approved: Sponsor Contact Information Ethitek Pharmaceuticals, Inc. 7855 Gross Point Road, Unit L Skokie IL 60077 Generic Name: Morphine sulfate concentrate (preservative free) Trade Name (if present): Infumorph Date Designated 7/12/1990 Date Approved 7/19/1991 Designation Approved: For intrathecal or epidural infusion in the treatment of tractable chronic pain. It was developed for use in continuous microinfusion devices and may require dilution before use as directed. Sponsor Contact Information Elkins-Sinn, Inc. 2 Esterbrook Lane Cherry Hill NJ 08003 Generic Name: motexafin gadolinium Trade Name (if present): Xcytrin Date Designated 1/27/2003 Date Approved Designation Approved: Sponsor Contact Information Pharmacyclics, Inc. 999 East Arques Avenue Sunnyvale CA 94085-4521 Generic Name: MTC-DOX for Injection Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/3/2001 Date Approved FeRx Incorporated 4330 La Jolla Village Drive Suite #250 San Diego CA 92122 Generic Name: Mucoid exopolysaccharide Pseudomonas hyperimmune globulin Trade Name (if present): MEP IGIV Date Designated 1/9/1991 Date Approved Designation Approved: Sponsor Contact Information North American Biologicals, Inc. 12280 Wilkins Avenue Rockville MD 20852 Generic Name: Mucoid exopolysaccharide Pseudomonas hyperimmune globulin Trade Name (if present): MEP IGIV Date Designated 11/7/1990 Date Approved Designation Approved: Sponsor Contact Information North American Biologicals, Inc. 12280 Wilkins Avenue Rockville MD 20852 Generic Name: Multi-ligand somatostatin analogue Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/27/2004 Date Approved Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Multi-vitamin infusion (neonatal formula) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/12/1989 Date Approved Astra Pharmaceuticals, L.P. 725 Chesterbrook Blvd. Wayne PA 19087-5677 Generic Name: multi-vitiam infusion without vitamin K Trade Name (if present): M.V.I.-12 Date Designated 3/8/2004 Date Approved 9/9/2004 Designation Approved: Prevention of vitamin deficiency and thrombormbolic complications in people receiving home parenteral nutrition who also receive warfarin-type anticoagulant therapy Sponsor Contact Information Mayne Pharma (USA) Inc. Mack-Cali Centre II Second Floor Paramus NJ 07652 Generic Name: Murine MAb (Lym-1) and Iodine 131-I radiolabeled murine MAb (Lym-1) to human B-cell lymphoma Trade Name (if present): Oncolym Date Designated 11/27/1998 Date Approved Designation Approved: Sponsor Contact Information Peregrine Pharmaceuticals, Inc. 14272 Franklin Ave. Suite 100 Tustin CA 92780 Generic Name: Murine MAb to polymorphic epithelial mucin, human milk fat globule 1 Trade Name (if present): Theragyn Date Designated 3/22/1999 Date Approved Designation Approved: Sponsor Contact Information Antisoma plc West Africa House Hanger Lane Ealing London W5 3QR UNITED KINGDOM Generic Name: Mx-dnG1 or Rexin-G retroviral vector Trade Name (if present): REXIN-G Date Designated 8/15/2003 Date Approved Designation Approved: Sponsor Contact Information Epeius Biotechnologies Corporation 345 Pioneer Drive, 1803W Glendale CA 91203 Generic Name: Mycobacterium avium sensitin RS-10 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/1995 Date Approved Statens Seruminstitut 5 Artillerivej DK-2300 Copenhagen S SWEDEN Generic Name: Mycophenolate mofetil Trade Name (if present): CellCept Date Designated 5/26/2006 Date Approved Designation Approved: Sponsor Contact Information Hoffman-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Myelin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/27/1991 Date Approved AutoImmune, Inc. 128 Spring Street Lexington MA 02173 Generic Name: myo-inositol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/7/2005 Date Approved Ross Products Division Abbott Laboratories 625 Cleveland Ave. Columbus OH 43215-1724 Generic Name: myristoylated recombinant SCR1-3 of human complement reseptor type I Trade Name (if present): APT070 Date Designated 5/21/2003 Date Approved Designation Approved: Sponsor Contact Information Inflazyme Pharmaceuticals, Ltd. 5600 Parkwood Way Suite 425 CANADA Generic Name: N-((methyl-diazacyclohexylmethylbenzamide)-asaphenylaminothiopyrrole) mesylate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/20/2005 Date Approved AB Science 3, avenue George V FRANCE Generic Name: N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'(trifluoromethyl)[1,1'biphenyl]-2yl]carbonyl]amino]-1-piperidinyl]butyl]-9Hfluorene-9-carboxamide, methanesulfonate salt Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/23/2007 Date Approved Aegerion Pharmaceuticals, Inc. Center Pointe IV Suite 304 Bridgewater NJ 08807 Generic Name: N-(2,3-dihydro-3,3-dimethyl-1H-indol-6-yl)-2[(4-pyridinylmethyl)amino]-3pyridinecarboxamide, phosphate (1:2) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/13/2005 Date Approved Amgen, Inc. One Amgen Center Drive Thousand Oaks CA 91320-1799 Generic Name: N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4dihydro-4-oxoquinoline-3-carboxamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/20/2006 Date Approved Vertex Pharmaceuticals, Inc. 130 Waverly St. Cambridge MA 02139-4242 Generic Name: N-(2-amino-phenyl)-4-[(4-pyridin-3-ylpyrimidin-2-ylamino)-methyl] benzamide dihydrobromide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/8/2007 Date Approved Pharmion Corporation 2525 - 28th Street Boulder CO 80301 Generic Name: N-(2-amino-phenyl)-4-[(4-pyridin-3-ylpyrimidin-2-ylamino)-methyl] benzamide dihydrobromide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/2008 Date Approved Pharmion Corporation 2525 - 28th Street Boulder CO 80301 Generic Name: N-(methyl-diazacyclohexylmethylbenzamide)-azaphenylTrade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/17/2005 Date Approved AB Science 3, avenue George V FRANCE Generic Name: N-[2-[(4-hydroxyphenyl)amino]-3-pyridinyl]4-methoxybenzenesulfonamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/30/2004 Date Approved Abbott Laboratories Pharmaceuticals Products Division D-491, AP30-1E Abbott Park IL 60064-6157 Generic Name: N-[3-(4',5'-bipyrimidin-2-ylamino)-4methylphenyl]-4-{[(3S)-3(dimethylamino)pyrrolidin-1-yl]methyl}-3(trifluoromethyl)benzamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/27/2006 Date Approved Innovive Pharmaceuticals 555 Madison Avenue New York NY 10022 Generic Name: N-[4-(3-amino-1H-indazol-4-yl)phenyl]-N1-(2fluoro-5-methylphenyl) urea Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/23/2007 Date Approved Abbott Laboratories Global Pharmaceuticals Research & Development 200 Abbott Park Road Abbott Park IL 60064-6157 Generic Name: N-[4-(3-amino1H-indazol-4-yl)phenyl]-N1-(2fluoro-5-methylphenyl)urea Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/23/2007 Date Approved Abbott Laboratories Global Pharmaceuticals Research & Development 200 Abbott Park Road Abbott Park IL 60064-6157 Generic Name: N-[4-(4-amino-2-ethyl-1H-imidazo[4,5c]quinolin-1-yl)butyl]methanesulfonamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/13/2004 Date Approved Coley Pharmaceuticals Group, Inc. 93 Worcester Street Suite 101 Wellesley MA 02481 Generic Name: N-[4-(4-amino-2-ethyl-lH-imidazo[4,5c]quinolin-1-yl)butyl]methanesulfonamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/24/2006 Date Approved Pfizer, Inc. 50 Pequot Avenue 6025-A3106 New London CT 06320 Generic Name: N-[4-bromo-2-(1H-1,2,3,4-tetrazol-5yl)phenyl]-N'-[3,5Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/13/2002 Date Approved NeuroSearch A/S 93 Pederstrupvej DK-2750 Ballerup DENMARK Generic Name: N2'-Deacetyl-N2'-[4-methyl-4(oxobuthyldithio)-1-oxopentyl]-maytansinechimerized anti-CD138 IgG4 Monoclonal Antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/27/2008 Date Approved Biotest Pharmaceuticals Corporation 5800 Park of Commerce Blvd., NW Boca Raton FL 33487 Generic Name: N-acetylcysteinate Lysine Trade Name (if present): Nacystelyn Dry Powder Inhaler Date Designated 12/27/2000 Date Approved Designation Approved: Sponsor Contact Information Galephar Pharmaceutical Research, Inc. Road 198, No. 100 km. 14.7 Juncos Industrial Park Juncos 00777-3873 PUERTO RICO Generic Name: N-acetylcysteine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/9/2002 Date Approved William M. Lee, MD, FACP University of Texas Southwestern Medical Center at 5323 Harry Hines Blvd Dallas TX 75390-9151 Generic Name: N-acetylgalactosamine-4-sulfatase, recombinant human Trade Name (if present): Naglazyme Date Designated 2/17/1999 Date Approved 5/31/2005 Designation Approved: For patients with mucopolysaccharidosis VI. Galsulfase has been shown to improve walking and stair-climbing capacity. Sponsor Contact Information BioMarin Pharmaceutical, Inc. 105 Digital Drive Novato CA 94949-5608 Generic Name: N-acetyl-glucosamine thiazoline Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/6/2006 Date Approved ExSAR Corporation 11 Deer Park Drive Monmouth Junction NJ 08852 Generic Name: N-acetylprocainamide Trade Name (if present): Napa Date Designated 3/23/1990 Date Approved Designation Approved: Sponsor Contact Information Medco Research, Inc. 8455 Beverly Blvd. Suite 308 Los Angeles CA 90048 Generic Name: N-acetyl-procainamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/10/1996 Date Approved NAPA of the Bahamas 3560 Pennsylvania Avenue, Suite 7 Dubuque IA 52002 Generic Name: N-acetyl-sarcosyl-glycyl-L-valyl-Dalloisoleucyl-L-threonyl-L-norvalyl-Lisoleucyl-L-arginyl_L-prolylethylaminde Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/9/2003 Date Approved Abbott Laboratories Pharmaceutical Products Division 200 Abbott Park Road Abbott Park IL 60064 Generic Name: N-adamantanyl-N'-Geranyl-ethylenediamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/16/2007 Date Approved Sequella, Inc. 9610 Medical Center Drive Rockville MD 20850 Generic Name: Nafarelin acetate Trade Name (if present): Synarel Nasal Solution Date Designated 7/20/1988 Date Approved 2/26/1992 Designation Approved: Treatment of central precocious puberty (gonadotropin-dependent precocious puberty) in children of both sexes. Sponsor Contact Information Syntex (USA), Inc. 3401 Hillview Avenue Palo Alto CA 94303 Generic Name: Naltrexone HCl Trade Name (if present): Trexan Date Designated 3/11/1985 Date Approved 11/30/1984 Designation Approved: Sponsor Contact Information DuPont Pharmaceuticals E.I. Du Pont De Nemours & Co. Wilmington DE 19880 Generic Name: natural human lymphoblastoid interferonalpha Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/18/2002 Date Approved Amarillo Biosciences, Inc. 4134 Business Park Drive Amarillo TX 79110 Generic Name: Natural human lymphoblastoid interferonalpha Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/18/2000 Date Approved Amarillo Biosciences, Inc. 4134 Business Park Drive Amarillo TX 79110 Generic Name: Natural human lymphoblastoid interferonalpha Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/10/2000 Date Approved Amarillo Biosciences, Inc. 4134 Business Park Drive Amarillo TX 79110 Generic Name: NDROGE Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/1/1984 Date Approved WATSON Laboratories, Inc. 33 Ralph Avenue P.O. Box 30 Copiaque NY 11726-0030 Generic Name: Nebacumab Trade Name (if present): Centoxin Date Designated 10/1/1986 Date Approved Designation Approved: Sponsor Contact Information Centocor, Inc. 200 Great Valley Parkway Malvern PA 19355 Generic Name: nelarabine Trade Name (if present): Arranon Date Designated 8/10/2004 Date Approved 10/28/2005 Designation Approved: Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens Sponsor Contact Information GlaxoSmithKline One Franklin Plaza Phildelphia PA 19101 Generic Name: Neurotrophin-1 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/13/1994 Date Approved Ericsson, Arthur Dale, M.D. 6560 Fannin, Scurlock Tower, Suite 720 Houston TX 77303 Generic Name: NG-29 Trade Name (if present): Somatrel Date Designated 8/8/1989 Date Approved Designation Approved: Sponsor Contact Information Ferring Laboratories, Inc. 400 Rella Boulevard, Suite 201 Suffern NY 10901 Generic Name: Nifedipine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/13/1991 Date Approved Fleischmann, Jonathan M.D. MetroHealth Medical Center 3395 Scranton Road Cleveland OH 44109 Generic Name: Nikkomycin Z Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/14/2006 Date Approved Valley Fever Center for Excellence (1-111 INF) University of Arizona Tucson AZ 85723 Generic Name: nilotinib Trade Name (if present): Tasigna Date Designated 3/20/2007 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaeuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Nilotinib Trade Name (if present): Tasigna Date Designated 4/27/2006 Date Approved 10/29/2007 Designation Approved: For the use for chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included GleevecÃ_Â®(imatinib) Sponsor Contact Information Novartis Pharmaceutical Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Nimotuzumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/17/2004 Date Approved YM Biosciences Inc. 5045 Orbitor Drive Mississauga, Ontario L4W 4Y4 CANADA Generic Name: niprisan Trade Name (if present): Hemoxin Date Designated 8/15/2003 Date Approved Designation Approved: Sponsor Contact Information Xechem International, Inc. 379 Thornall Road Edison NJ 08837 Generic Name: nitazoxanide Trade Name (if present): Cryptaz Date Designated 10/23/2001 Date Approved Designation Approved: Sponsor Contact Information Romark Laboratories, L.C. 6200 Courtney Campbell Causeway Suite 880 Tampa FL 33607 Generic Name: nitazoxanide Trade Name (if present): Alinia Date Designated 2/14/2002 Date Approved 11/22/2002 Designation Approved: Treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia Sponsor Contact Information Romark Laboratories, L.C. 6200 Courtney Campbell Causeway Suite 880 Tampa FL 33607 Generic Name: Nitazoxanide Trade Name (if present): Alinia Date Designated 12/12/1996 Date Approved 11/22/2002 Designation Approved: Treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia Sponsor Contact Information Romark Laboratories, L.C. 6200 Courtney Campbell Causeway Suite 880 Tampa FL 33607 Generic Name: Nitisinone Trade Name (if present): Orfadin Date Designated 10/19/2001 Date Approved Designation Approved: Sponsor Contact Information Swedish Orphan AB Kungsgatan 37, 7th Floor SE-111 56 SWEDEN Generic Name: Nitisinone Trade Name (if present): Orfadin Date Designated 5/16/1995 Date Approved 1/18/2002 Designation Approved: Adjunctive therapy to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 Sponsor Contact Information Swedish Orphan AB Drottninggatan 98 SE-111 60 Stockholm SWEDEN Generic Name: Nitric oxide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/16/2005 Date Approved SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda CA 92887-4645 Generic Name: Nitric oxide Trade Name (if present): INOmax Date Designated 9/27/2004 Date Approved Designation Approved: Sponsor Contact Information INO Therapeutics 6 Route 173 Clinton NJ 08809 Generic Name: Nitric oxide Trade Name (if present): INOmax Date Designated 6/22/1993 Date Approved 12/23/1999 Designation Approved: In conjunction with ventilatory support and other appropriate agents, in the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation. Sponsor Contact Information INO Therapeutics, Inc. 54 Old Highway 22 Clinton NJ 08809 Generic Name: Nitric oxide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/10/1995 Date Approved INO Therapeutics, Inc. 54 Old Highway 22 Clinton NJ 08809 Generic Name: Nitroprusside Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/21/2001 Date Approved Thomas, MD, Jeffrey Evan Thomas Jefferson University and Wills Neurosensory 834 Walnut Street, Suite 650 Philadelphia PA 19107-5102 Generic Name: N-malonyl-bis(N'-methyl-N'thiobenzoylhydrazide) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2007 Date Approved Synta Pharmaceuticals Corporation 45 Hartwell Ave. Lexington MA 02421 Generic Name: N-Methyl-2-[3-[((E)-2-pyridin-2-yl-vinyl)-1Hindazol-6-ylsulfanyl]benzamide Trade Name (if present): Axitinib Date Designated 5/4/2007 Date Approved Designation Approved: Sponsor Contact Information Pfizer, Inc. La Jolla Laboratories 10646 Science Center Drive San Diego CA 92121 Generic Name: Novel Acting Thrombolytic (NAT) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/26/2001 Date Approved Nuvelo, Inc. Inc. 201 Industrial Road Suite 310 San Carlos CA 94070- Generic Name: Nucleic acid aptamer binding to tumor cell nucleolin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/17/2004 Date Approved Antisoma Research Ltd. Hanger Lane Ealing UNITED KINGDOM Generic Name: Nucleic acid aptamer binding to tumor cell nucleon Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/28/2005 Date Approved Antisoma Research Ltd. Hanger Lane Ealing, London UNITED KINGDOM Generic Name: NZ-1002 Trade Name (if present): Designation Approved: Enzyme replacement therapy in patients with all subtypes of Mucopolysaccharidosis I. Sponsor Contact Information Date Designated 4/11/2001 Date Approved Novazyme Pharmaceuticals, Inc. 800 Research Parkway Suite 200 Oklahoma City OK 73104 Generic Name: Obatoclax mesylate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/8/2004 Date Approved Gemin X, Inc. 5 Great Valley Parkway Malvern PA 19355 Generic Name: Obatoclax mesylate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/6/2006 Date Approved Gemin X, Inc. 5 Great Valley Parkway Malvern PA 19355 Generic Name: Obatoclax mesylate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/1/2006 Date Approved Gemin X, Inc. 400 Chesterfield Pkwy. Malvern PA 19355 Generic Name: oblimersen Trade Name (if present): Genasense Date Designated 7/31/2000 Date Approved Designation Approved: Sponsor Contact Information Genta, Inc. Two Connell Drive Berkeley Heights NJ 07922 Generic Name: Octreotide Trade Name (if present): Sandostatin LAR Date Designated 8/24/1998 Date Approved 11/25/1998 Designation Approved: Supression of severe diarrhea and flushing associated with malignant carcinoid syndrome. Sponsor Contact Information Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover NJ 07936-1080 Generic Name: Octreotide Trade Name (if present): Sandostatin LAR Date Designated 8/24/1998 Date Approved 11/25/1998 Designation Approved: Reduction of growth hormone and IGF-1 (somatomedin C) in acromegaly. Sponsor Contact Information Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover NJ 07936-1080 Generic Name: Octreotide Trade Name (if present): Sandostatin LAR Date Designated 8/24/1998 Date Approved 11/25/1998 Designation Approved: Treatment of profuse watery diarrhea associated with VIPoma. Sponsor Contact Information Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover NJ 07936-1080 Generic Name: Ofloxacin Trade Name (if present): Ocuflox Ophthalmic Solution Date Designated 4/18/1991 Date Approved 5/22/1996 Designation Approved: Treatment of bacterial corneal ulcers. Sponsor Contact Information Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine CA 92713 Generic Name: oglufanide disodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/24/2001 Date Approved Implicit Bioscience Pty Ltd P. O. Box 2072 Toowong Business Center AUSTRALIA Generic Name: OM 401 Trade Name (if present): Drepanol Date Designated 10/24/1991 Date Approved Designation Approved: Sponsor Contact Information Omex International, Inc. 6001 Savoy, Suite 110 Houston TX 77036 Generic Name: Omacetaxine mepesuccinate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/10/2006 Date Approved ChemGenex Pharmaceuticals, Inc. 3715 Haven Avenue Menlo Park CA 94025 Generic Name: Omega-3 (n-3) polyunsaturated fatty acid with all double bonds in the cis Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/22/1995 Date Approved Research Triangle Pharmaceuticals 4364 South Alston Avenue Durham NC 27713 Generic Name: Omega-3 (n-3) polyunsaturated fatty acids Trade Name (if present): Omacor Date Designated 5/4/2000 Date Approved Designation Approved: Sponsor Contact Information Pronova Biocare, AS PO Box 420 1327 Lysaker NORWAY Generic Name: Omegaven emulsion Trade Name (if present): Omegaven Date Designated 2/27/2008 Date Approved Designation Approved: Sponsor Contact Information Fresenius Kabi Deutschland GmbH Daimlerstrasse 16 GERMANY Generic Name: Oncorad Ov103 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/24/1990 Date Approved Cytogen Corporation 600 College Road East Princeton NJ 08540 Generic Name: Oprelvekin Trade Name (if present): Neumega Date Designated 12/17/1996 Date Approved 11/25/1997 Designation Approved: Sponsor Contact Information Genetics Institute, Inc. 87 Cambridge Park Drive Cambridge MA 02140 Generic Name: oral unfractionated heparin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/29/2004 Date Approved TRF Technologies, Inc. 863 Mitten Road, Suite 101 Burlingame CA 94010 Generic Name: Orgotein for injection Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/22/1994 Date Approved Oxis International, Inc. 6040 N. Cutter Circle, Suite 317 Portland OR 97217-3935 Generic Name: ortezomib Trade Name (if present): Velcade Date Designated 1/15/2003 Date Approved 5/13/2003 Designation Approved: Treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy Sponsor Contact Information Millennium Pharmaceuticals, Inc. 40 Landsdowne Street Cambridge MA 02139 Generic Name: Oxaliplatin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/6/1992 Date Approved Debio Pharm S.A. Rue des Terreaux 17 CH-1000 SWITZERLAND Generic Name: Oxalobacter formigenes Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/29/2006 Date Approved OxThera, Inc. 13709 Progress Blvd. #17 Alachua FL 32615 Generic Name: Oxandrolone Trade Name (if present): Oxandrin Date Designated 7/5/1990 Date Approved Designation Approved: Sponsor Contact Information Bio-Technology General Corp. 70 Wood Avenue, South Iselin NJ 08830 Generic Name: Oxandrolone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/5/1990 Date Approved Bio-Technology General Corp. 70 Wood Avenue, South Iselin NJ 08830 Generic Name: Oxandrolone Trade Name (if present): Oxandrin Date Designated 4/22/1997 Date Approved Designation Approved: Sponsor Contact Information Savient Pharmaceuticals, Inc. One Tower Center Boulevard, 12th floor East Brunswick NJ 08816 Generic Name: Oxandrolone Trade Name (if present): Oxandrin Date Designated 9/6/1991 Date Approved Designation Approved: Sponsor Contact Information Bio-Technology General Corp. One Tower Center Boulevard, 12 th floor East Brunswick NJ 08816 Generic Name: Oxandrolone Trade Name (if present): Hepandrin Date Designated 3/18/1994 Date Approved Designation Approved: Sponsor Contact Information Bio-Technology General Corp. 70 Wood Avenue South Iselin NJ 08830 Generic Name: oxybate Trade Name (if present): Xyrem Date Designated 11/7/1994 Date Approved 11/18/2005 Designation Approved: Treatment of excessive daytime sleepiness in patients with narcolepsy Sponsor Contact Information Jazz Pharmaceuticals 3180 Porter Drive Palo Alto CA 94304 Generic Name: oxybate Trade Name (if present): Xyrem Date Designated 11/7/1994 Date Approved 7/17/2002 Designation Approved: Treatment of cataplexy associated with narcolepsy. Sponsor Contact Information Jazz Pharmaceuticals 3180 Porter Drive Palo Alto CA 94304 Generic Name: Oxymorphone Trade Name (if present): Numorphan H.P. Date Designated 3/19/1985 Date Approved Designation Approved: Sponsor Contact Information DuPont Merck Pharmaceutical Company P.O. Box 80027 Wilmington DE 19880 Generic Name: Oxypurinol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/9/1998 Date Approved Cardiome Pharma Corp. 3650 Westbrook Mall Vancouver, B.C. CANADA Generic Name: p1-(uridine 5'-)-p4-(2'-deoxycytidine 5'-) tetraphosphate, tetrasodium salt Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/7/2001 Date Approved Inspire Pharmaceuticals, Inc. 4222 Emperor Blvd. Suite 470 Durham NC 27703 Generic Name: P1, P4-Di(uridine 5'-tetraphosphate), tetrasodium salt Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/27/1998 Date Approved Inspire Pharmaceuticals, Inc. 4222 Emperor Blvd., Suite 470 Durham NC 27703 Generic Name: Paclitaxel Trade Name (if present): Taxol Date Designated 3/25/1997 Date Approved 8/4/1997 Designation Approved: For the second line treatment of AIDS-related Kaposi's sarcoma. Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute 5 Research Parkway P.O. Box 5100 Wallingford CT 06492-7660 Generic Name: Paclitaxel Trade Name (if present): Paxene Date Designated 4/15/1997 Date Approved Designation Approved: Sponsor Contact Information Baker Norton Pharmaceuticals, Inc. 4400 Biscayne Boulevard Miami FL 33137 Generic Name: paclitaxel aqueous gel Trade Name (if present): OncoGel Date Designated 2/1/2008 Date Approved Designation Approved: Sponsor Contact Information Protherics, Inc. 5214 Maryland Way Brentwood TN 37027 Generic Name: Pafuramidine maleate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/31/2007 Date Approved Immtech Pharmaceuticals, Inc. 150 Fairway Drive Vernon Hills IL 60061 Generic Name: Pafuramidine maleate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/14/2007 Date Approved Immtech Pharmaceuticsl, Inc. 150 Fairway Drive Vernon Hills IL 60061 Generic Name: pafuramidine maleate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/17/2006 Date Approved Immtech Pharmaceuticals, Inc. 150 Fairway Drive Suite 150 Vernon Hills IL 60061 Generic Name: Panobinostat Trade Name (if present): Faridak Date Designated 9/26/2007 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaceuticals Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Papain, trypsin, and chymotrypsin Trade Name (if present): Wobe-Mugos Date Designated 12/21/1998 Date Approved Designation Approved: Sponsor Contact Information Marlyn Nutraceuticals, Inc. 14851 N. Scottsdale Rd. Scottsdale AZ 85254 Generic Name: parathyroid hormone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/31/2007 Date Approved NPS Pharmaceuticals, Inc. 300 Interpace Parkway Parsippany NJ 07054 Generic Name: paromomycin sulfate/gentamicin sulfate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/18/2008 Date Approved Office of the Surgeon General Department of the Army 1430 Veteran's Drive Ft. Detrick MD 21702 Generic Name: Parvovirus B19 (recombinant VP1 and VP2; S.frugiperda cells) vaccine Trade Name (if present): MEDI-491 Date Designated 5/7/1999 Date Approved Designation Approved: Sponsor Contact Information MedImmune, Inc. 35 West Watkins Mill Rd. Gaithersburg MD 20878 Generic Name: Patul-end Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/18/1997 Date Approved Ear Foundation 2420 Castillo Street, Suite 100 Santa Barbara CA 93105 Generic Name: Patupilone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/4/2005 Date Approved Novartis Pharmaceutical Corporation One Health Plaza East Hanover NJ 07936-1080 Generic Name: Pegademase bovine Trade Name (if present): Adagen Date Designated 5/29/1984 Date Approved 3/21/1990 Designation Approved: Sponsor Contact Information Enzon, Inc. 20 Kingsbridge Road Piscataway NJ 08854 Generic Name: Pegaspargase Trade Name (if present): Oncaspar Date Designated 10/20/1989 Date Approved 2/1/1994 Designation Approved: Combination chemotherapy for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to native forms of Lasparaginase. Sponsor Contact Information Enzon, Inc. 20 Kingsbridge Road Piscataway NJ 08854 Generic Name: PEG-glucocerebrosidase Trade Name (if present): Lysodase Date Designated 12/9/1992 Date Approved Designation Approved: Sponsor Contact Information National Institute of Mental Health, NIH 49 Convent Dr. MSC4405 Bldg. 49, Room B1EE16 Bethesda MD 20892-4405 Generic Name: Peginterferon alfa-2a Trade Name (if present): PEGASYS Date Designated 9/30/1999 Date Approved Designation Approved: Sponsor Contact Information Hoffman-La Roche Inc. 340 Kingsland St. Nutley NJ 07110-1199 Generic Name: Peginterferon alfa-2a Trade Name (if present): PEGASYS Date Designated 7/13/1998 Date Approved Designation Approved: Sponsor Contact Information Hoffman-La Roche Inc. 340 Kingsland St. Nutley NJ 07110-1199 Generic Name: peginterferon alfa-2b Trade Name (if present): PegIntron Date Designated 4/9/2008 Date Approved Designation Approved: Sponsor Contact Information Schering-Plough Corporation 2000 Galloping Hill Road Kenilworth NJ 07933-0530 Generic Name: PEG-interleukin-2 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/1990 Date Approved Chiron Corporation 4560 Horton Street Emeryville CA 94608 Generic Name: Pegvisomant Trade Name (if present): Somavert Date Designated 6/24/1997 Date Approved 3/25/2003 Designation Approved: Treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate Sponsor Contact Information Sensus Corporation Suite 430, 98 San Jacinto Boulevard Austin TX 78701 Generic Name: Pegylated arginine deiminase Trade Name (if present): Melanocid Date Designated 4/12/1999 Date Approved Designation Approved: Sponsor Contact Information Phoenix Pharmacologics, Inc. 115 John Robert Thomas Dr. Exton PA 19341 Generic Name: Pegylated arginine deiminase Trade Name (if present): Hepacid Date Designated 3/26/1999 Date Approved Designation Approved: Sponsor Contact Information Phoenix Pharmacologics, Inc. 115 John Robert Thomas Dr. Exton PA 19341 Generic Name: Pegylated recombinant human megakaryocyte growth and development factor Trade Name (if present): MEGAGEN Date Designated 10/20/1997 Date Approved Designation Approved: Sponsor Contact Information Amgen, Inc. One Amgen Center Dr. Thousand Oaks CA 91320-1789 Generic Name: Peldesine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/5/1993 Date Approved BioCryst Pharmaceuticals, Inc. 2190 Parkway Lake Drive Birmingham AL 35244 Generic Name: pemetrexed disodium Trade Name (if present): Alimta Date Designated 8/28/2001 Date Approved 2/4/2004 Designation Approved: Treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery Sponsor Contact Information Eli Lilly and Company Lilly Corporate Center Indianapolis IN 46285 Generic Name: Pentamidine isethionate Trade Name (if present): Nebupent Date Designated 1/12/1988 Date Approved 6/15/1989 Designation Approved: Sponsor Contact Information Fujisawa USA, Inc. 3 Parkway North Center Deerfield IL 60015 Generic Name: Pentamidine isethionate Trade Name (if present): Pentam 300 Date Designated 2/28/1984 Date Approved 10/16/1984 Designation Approved: Sponsor Contact Information Fujisawa USA, Inc. 3 Parkway North Center Deerfield IL 60015 Generic Name: Pentamidine isethionate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/29/1984 Date Approved Aventis Behring L.L.C. 1020 First Avenue PO Box 61501 King of Prussia PA 19406-0901 Generic Name: Pentamidine isethionate (inhalation) Trade Name (if present): Pneumopent Date Designated 10/5/1987 Date Approved Designation Approved: Sponsor Contact Information Fisons Corporation 755 Jefferson Rd., P.O. Box 1710 Rochester NY 14603 Generic Name: Pentastarch Trade Name (if present): Pentaspan Date Designated 8/28/1985 Date Approved 5/19/1987 Designation Approved: Sponsor Contact Information Du Pont Pharmaceuticals E.I. Du Pont De Nemours & Co. Wilmington DE 19898 Generic Name: pentetate trisodium Trade Name (if present): diethylenetriaminepentaacetate Date Designated 4/12/2004 Date Approved Designation Approved: Sponsor Contact Information Heyl Chemisch-Pharmazeutische Fabrik GMBH & Co. KG Goerzallee 253 Fedderal of Republic of Germany GERMANY Generic Name: Pentosan polysulfate sodium Trade Name (if present): Elmiron Date Designated 8/7/1985 Date Approved 9/26/1996 Designation Approved: Relief of bladder pain or discomfort associated with interstitial cystitis. Sponsor Contact Information Alza Corporation 950 Page Mill Rd. PO Box 10950 Palo Alto CA 94303-0802 Generic Name: Pentostatin Trade Name (if present): Nipent Date Designated 1/29/1991 Date Approved Designation Approved: Sponsor Contact Information SuperGen, Inc. 4140 Dublin Blvd. Suite 200 Dublin CA 94568 Generic Name: Pentostatin Trade Name (if present): Nipent Date Designated 11/24/1999 Date Approved Designation Approved: Sponsor Contact Information SuperGen, Inc. 4140 Dublin Blvd. Suite 200 Dublin CA 94568 Generic Name: Pentostatin Trade Name (if present): Nipent Date Designated 3/27/1998 Date Approved Designation Approved: Sponsor Contact Information SuperGen, Inc. 4140 Dublin Blvd. Suite 200 Dublin CA 94568 Generic Name: Pentostatin for injection Trade Name (if present): Nipent Date Designated 9/10/1987 Date Approved 10/11/1991 Designation Approved: Single agent treatment for adult patients with alpha-interferon-refractory hairy cell leukemia. Sponsor Contact Information SuperGen, Inc. 4140 Dublin Blvd. Suite 200 Dublin CA 94568 Generic Name: Peptide 144 TGF beta-1 inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/27/2006 Date Approved Digna Biotech, S.L. Avenida Carlos III el Noble Pamplona (Navarra) SPAIN Generic Name: Peptide 144 TGF beta-1-inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/26/2006 Date Approved Digna Biotech, S.L. Avenida Carlos III el Noble, 36, 1 Dcha. 31003 SPAIN Generic Name: Peptidomimetic analog of hexarelin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/14/2007 Date Approved Ardana Bioscience Ltd. 38 Melville Street Scotland UNITED KINGDOM Generic Name: Perflubron Trade Name (if present): LiquiVent Date Designated 4/26/2001 Date Approved Designation Approved: Sponsor Contact Information Alliance Pharmaceutical Corp. 3040 Science Park Road San Diego CA 92191 Generic Name: Perfosfamide Trade Name (if present): Pergamid Date Designated 12/4/1989 Date Approved Designation Approved: Sponsor Contact Information Scios Nova, Inc. 2450 Bayshore Parkway Mountain View CA 94043 Generic Name: Pergolide Trade Name (if present): Permax Date Designated 11/20/1997 Date Approved Designation Approved: Sponsor Contact Information Sallee, Floyd R. M.D., Ph.D. Cincinnati Children's Hospital Medical Center 3333 Burnet Ave. Cincinnati OH 45229-3039 Generic Name: Phenylacetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/6/1998 Date Approved Elan Drug Delivery, Inc. 1300 Gould Dr. Gainesville GA 30504 Generic Name: Phenylalanine ammonia-lyase Trade Name (if present): Phenylase Date Designated 3/8/1995 Date Approved Designation Approved: Sponsor Contact Information Biomarin Pharmaceutical 105 Digital Drive Novato CA 94949 Generic Name: Phenylbutyrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/19/2000 Date Approved Elan Drug Delivery, Inc. 1300 Gould Dr. Gainesville GA 30504 Generic Name: phenylephrine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/14/2002 Date Approved S.L.A. Pharma Unit 3, Hill Farm Industrial Estate Leavesden, Watford UNITED KINGDOM Generic Name: Phosphocysteamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/12/1988 Date Approved Medea Research Laboratories Port Jefferson Business Center 200 Wilson Street, Building D-6 Port Jefferson NY 11776 Generic Name: phosphorothioate oligonucleotide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/9/2007 Date Approved Isis Pharmaceuticals, Inc. 1896 Rutherford Road Carlsbad CA 92008 Generic Name: Picoplatin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/2/2005 Date Approved Poniard Pharmaceuticals 300 Elliott Avenue West Seattle WA 98119 Generic Name: Pilocarpine Trade Name (if present): Salagen Date Designated 9/24/1990 Date Approved 3/22/1994 Designation Approved: Treatment of symptoms of xerostomia from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck. Sponsor Contact Information MGI Pharma, Inc. 5775 West Old Shakopee Rd. Suite 100 Bloomington MN 55437-3107 Generic Name: Pilocarpine HCl Trade Name (if present): Salagen Date Designated 2/28/1992 Date Approved 2/11/1998 Designation Approved: Treatment of dry mouth in patients with Sjogren's syndrome. Sponsor Contact Information MGI Pharma, Inc. 5775 West Old Shakopee Rd. Suite 100 Bloomington MN 55437-3107 Generic Name: Piracetam Trade Name (if present): Nootropil Date Designated 10/2/1987 Date Approved Designation Approved: Sponsor Contact Information UCB, Inc. 1950 Lake Park Drive Smyrna GA 30080 Generic Name: Piritrexim isethionate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/13/1988 Date Approved Burroughs Wellcome Company 3030 Cornwallis Road P.O. Box 12700 Research Triangle Park NC 27709 Generic Name: Plasmid DNA vector expressing cystic fibrosis transmembrane gene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/29/2005 Date Approved Copernicus Therapeutics, Inc. 11000 Cedar Avenue Cleveland OH 44106 Generic Name: Plevitrexed Trade Name (if present): Plevitrexed Date Designated 5/14/2007 Date Approved Designation Approved: Sponsor Contact Information BTG International, Ltd 10 Fleet Place London EC4M 7SB UNITED KINGDOM Generic Name: Plevitrexed Trade Name (if present): Plevitrexed Date Designated 5/29/2007 Date Approved Designation Approved: Sponsor Contact Information BTG International Ltd 10 Fleet Place London EC4M 7SB UNITED KINGDOM Generic Name: Plitidepsin Trade Name (if present): Aplidin Date Designated 6/18/2004 Date Approved Designation Approved: Sponsor Contact Information PharmaMar USA, Inc University Park at M.I.T. The Richards Building 64 Cambridge MA 02139-4170 Generic Name: Plitidepsin Trade Name (if present): Aplidin Date Designated 9/30/2004 Date Approved Designation Approved: Sponsor Contact Information PharmaMar USA, Inc. University Park at M.I.T. The Rishards Building Cambridge MA 02139-4170 Generic Name: polifeprosan 20 with carmustine Trade Name (if present): Gliadel Date Designated 12/13/1989 Date Approved 2/25/2003 Designation Approved: Expanding the indication to include patients with malignant glioma undergoing primary surgical resection. Sponsor Contact Information Guilford Pharmaceuticals, Inc. 6611 Tributary Street Baltimore MD 21224 Generic Name: polifeprosan 20 with carmustine Trade Name (if present): Gliadel Date Designated 12/13/1989 Date Approved 9/23/1996 Designation Approved: As an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated Sponsor Contact Information Guilford Pharmaceuticals, Inc. 6611 Tributary Street Baltimore MD 21224 Generic Name: Poloxamer 188 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/5/1997 Date Approved CytRx Corporation 154 Technology Parkway Norcross GA 30092 Generic Name: Poloxamer 188 Trade Name (if present): Flocor Date Designated 6/27/1989 Date Approved Designation Approved: Sponsor Contact Information SynthRx Corporation 4606 Willow Bellaire TX 77401 Generic Name: Poloxamer 188 Trade Name (if present): Florcor Date Designated 2/22/1990 Date Approved Designation Approved: Sponsor Contact Information CytRx Corporation 154 Technology Parkway Norcross GA 30092 Generic Name: Poloxamer 331 Trade Name (if present): Protox Date Designated 3/21/1991 Date Approved Designation Approved: Sponsor Contact Information CytRx Corporation 154 Technology Parkway Norcross GA 30092 Generic Name: Poly I: poly C12U Trade Name (if present): Ampligen Date Designated 5/20/1991 Date Approved Designation Approved: Sponsor Contact Information Hemispherx Biopharma, Inc. One Penn Center 1617 JFK Boulevard Philadelphia PA 19103 Generic Name: Poly I: poly C12U Trade Name (if present): Ampligen Date Designated 12/9/1993 Date Approved Designation Approved: Sponsor Contact Information Hemispherx Biopharma, Inc. One Penn Center 1617 JFK Boulevard Philadelphia PA 19103 Generic Name: Poly I: poly C12U Trade Name (if present): Ampligen Date Designated 12/9/1993 Date Approved Designation Approved: Sponsor Contact Information Hemispherx Biopharma, Inc. One Penn Center 1617 JFK Boulevard Philadelphia PA 19103 Generic Name: Poly I: poly C12U Trade Name (if present): Ampligen Date Designated 7/19/1988 Date Approved Designation Approved: Sponsor Contact Information Hemispherx Biopharma, Inc. One Penn Center 1617 JFK Boulevard Philadelphia PA 19103 Generic Name: Polyethylene glycol (PEG)-uricase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/21/2001 Date Approved Savient Pharmaceuticals, Inc. One Tower Center Boulevard, 14th floor East Brunswick NJ 08816 Generic Name: Polyethylene glycol-modified uricase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/6/2005 Date Approved Phoenix Pharmacologics, Inc. 115 John Robert Thomas Dr. Exton PA 19341 Generic Name: Polyethylene glycol-modified uricase Trade Name (if present): Zurase Date Designated 9/14/1999 Date Approved Designation Approved: Sponsor Contact Information Phoenix Pharmacologics, Inc. 115 John Robert Thomas Dr. Exton PA 19341 Generic Name: Polyethylene glycol-modified uricase Trade Name (if present): Zurase Date Designated 12/21/1998 Date Approved Designation Approved: Sponsor Contact Information Phoenix Pharmacologics, Inc. 115 John Robert Thomas Dr. Exton PA 19341 Generic Name: Poly-ICLC Trade Name (if present): Hiltonol Date Designated 3/17/1997 Date Approved Designation Approved: Sponsor Contact Information Oncovir 3202 Cleveland Avenue N.W. Washington DC 20008 Generic Name: polyinosinic-polycytidilic acid Trade Name (if present): Poly-ICLC Date Designated 3/3/2003 Date Approved Designation Approved: Sponsor Contact Information Oncovir 3203 Cleveland Ave., NW Washington DC 20008-3450 Generic Name: polyinosinic-polycytidilic acid Trade Name (if present): Poly-ICLC Date Designated 8/2/2002 Date Approved Designation Approved: Sponsor Contact Information Oncovir 3203 Cleveland Ave., NW Washington DC 20008-3450 Generic Name: polyinosinic-polycytidilic acid (Poly-ICLC) Trade Name (if present): Hiltonol Date Designated 11/19/2002 Date Approved Designation Approved: Sponsor Contact Information Oncovir 3203 Cleveland Ave., NW Washington DC 20008-3450 Generic Name: Polymeric oxygen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/25/1992 Date Approved Capmed USA P.O. Box 14 Bryn Mawr PA 19010 Generic Name: Polyvalent, shed-antigen melanoma vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/9/2006 Date Approved Polynoma LLC 11622 El Camino Real #100 San Diego CA 92130 Generic Name: Porcine fetal neural dopaminergic cells and/or precursors aseptically prepared and coated with anti-MHC-1 Ab for intracerebral implantation Trade Name (if present): NeuroCell-PD Date Designated 12/17/1996 Date Approved Designation Approved: Sponsor Contact Information Diacrin/Genzyme LLC One Kendall Square Cambridge MA 02139-1562 Generic Name: Porcine fetal neural dopaminergic cells and/or precursors aseptically prepared for intracerebral implantation. Trade Name (if present): NeuroCell-PD Date Designated 12/17/1996 Date Approved Designation Approved: Sponsor Contact Information Diacrin/Genzyme LLC One Kendall Square Cambridge MA 02139-1562 Generic Name: Porcine fetal neural gabaergic cells and/or precursors aseptically prepared and coated with anti-MHC-1 Ab for intracerebral implantation Trade Name (if present): NeuroCell-HD Date Designated 12/10/1996 Date Approved Designation Approved: Sponsor Contact Information Diacrin/Genzyme LLC One Kendall Square Cambridge MA 02129-1562 Generic Name: Porcine fetal neural gabaergic cells and/or precursors aseptically prepared for intracerebral implantation for Huntington's disease. Trade Name (if present): NeuroCell-HD Date Designated 12/10/1996 Date Approved Designation Approved: Sponsor Contact Information Diacrin/Genzyme LLC One Kendall Square Cambridge MA 02139-1562 Generic Name: Porcine Sertoli cells aseptically prepared for intracerebral co-implantation with fetal neural tissue Trade Name (if present): N-Graft Date Designated 6/24/1997 Date Approved Designation Approved: Sponsor Contact Information Titan Pharmaceuticals, Inc. Post Office Plaza 50 Division Street, Suite 503 Somerville NJ 08876 Generic Name: porfimer Trade Name (if present): Photofrin Date Designated 10/19/2001 Date Approved 8/1/2003 Designation Approved: For the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy Sponsor Contact Information Axcan Scandipharm Inc. 22 Inverness Parkway Suite 310 Birmingham AL 35242 Generic Name: Porfimer sodium Trade Name (if present): Photofrin Date Designated 11/18/2004 Date Approved Designation Approved: Sponsor Contact Information Axcan Scandipharm Inc. 22 Inverness Parkway Birmingham AL 35242 Generic Name: Porfimer sodium Trade Name (if present): Photofrin Date Designated 6/6/1989 Date Approved 12/27/1995 Designation Approved: Photodynamic therapy with PHOTOFRIN for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who cannot be satisfactorily treated with Nd:YAG laser therapy. Sponsor Contact Information QLT Phototherapeutics, Inc. Lederle Laboratories 401 North Middletown Road Pearl River NY 10965 Generic Name: Porfimer sodium Trade Name (if present): Photofrin Date Designated 11/15/1989 Date Approved Designation Approved: Sponsor Contact Information QLT Phototherapeutics, Inc. Lederle Laboratories 401 North Middletown Road Pearl River NY 10965 Generic Name: Porfiromycin Trade Name (if present): Promycin Date Designated 3/13/1997 Date Approved Designation Approved: Sponsor Contact Information Boehringer Ingelheim Pharmaceuticals, Inc. 900 Ridgebury Road PO Box 368 Ridgefield CT 06877 Generic Name: Porfiromycin Trade Name (if present): Promycin Date Designated 9/19/1995 Date Approved Designation Approved: Sponsor Contact Information Boehringer Ingelheim Pharmaceuticals, Inc. 900 Ridgebury Road PO Box 368 Ridgefield CT 06877 Generic Name: Posaconazole Trade Name (if present): Posoril Date Designated 7/16/2004 Date Approved Designation Approved: Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilwortoh NJ 07033 Generic Name: Potassium citrate Trade Name (if present): Urocit-K Date Designated 11/1/1984 Date Approved 8/30/1985 Designation Approved: Sponsor Contact Information University of Texas Health Science Center at Dallas 5323 Harry Hines Blvd Dallas TX 75235 Generic Name: Potassium citrate Trade Name (if present): Urocit-K Date Designated 11/1/1984 Date Approved 8/30/1985 Designation Approved: Sponsor Contact Information University of Texas Health Science Center at Dallas 5323 Harry Hines Blvd Dallas TX 75235 Generic Name: Potassium citrate Trade Name (if present): Urocit-K Date Designated 11/1/1984 Date Approved 8/30/1985 Designation Approved: Sponsor Contact Information University of Texas Health Science Center at Dallas 5323 Harry Hines Boulevard Dallas TX 75235 Generic Name: Potassium citrate and citric acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/14/1986 Date Approved Willen Drug Company Generic Name: Potassium Iodide Oral Solution Trade Name (if present): ThyroShield Date Designated 11/17/2004 Date Approved 1/1/9999 Designation Approved: For use as a thyroid blocking agent in pediatric patients exposed to radiactive iodine Sponsor Contact Information Fleming & Company, Pharmaceuticals 1733 Gilsinn Lane Fenton MO 63026 Generic Name: potassium sodium aluminosilicate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/8/2007 Date Approved Framework Therapeutics, LLC 1564 33rd Street, NW Washington DC 20007 Generic Name: PR1 Vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/3/2004 Date Approved The Vaccine Company P. O. Box 93921 Carmel CA 93921 Generic Name: PR1 Vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/3/2004 Date Approved The Vaccine Company P. O. Box 93921 Carmel CA 93921 Generic Name: PR1 Vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/3/2004 Date Approved The Vaccine Company P. O. Box 93921 Carmel CA 93921 Generic Name: Pr-122 (redox-phenytoin) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/5/1990 Date Approved Pharmos 2 Innovation Drive Alachua FL 32615 Generic Name: PR-225 (redox-acyclovir) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/29/1990 Date Approved Pharmos 2 Innovation Drive Alachua FL 32615 Generic Name: PR-239 (redox penicillin G) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/23/1990 Date Approved Pharmos 2 Innovation Drive Alachua FL 32615 Generic Name: Pr-320 (molecusol-carbamazepine) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/20/1990 Date Approved Pharmos 2 Innovation Drive Alachua FL 32615 Generic Name: Pralatrexate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/20/2006 Date Approved Allos Therapeutics, Inc. 11080 CirclePoint Road Westminster CO 80020 Generic Name: pramipexole Trade Name (if present): Mirapex Date Designated 1/31/2008 Date Approved Designation Approved: Sponsor Contact Information Boehringer-Ingelheim Pharmaceuticals, Inc. 900 Ridgebury Road Ridgefield CT 06877 Generic Name: Pramiracetam Sulfate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/4/1991 Date Approved Cambridge Neuroscience, Inc. 1 Kendall Square, Bldg. 700 Cambridge MA 02139 Generic Name: Praziquantel Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/18/1988 Date Approved EM Pharmaceuticals, Inc. Generic Name: Prednimustine Trade Name (if present): Sterecyt Date Designated 6/17/1985 Date Approved Designation Approved: Sponsor Contact Information Pharmacia Inc. P.O. Box 16529 Columbus OH 43216-6529 Generic Name: Primaquine phosphate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/23/1993 Date Approved Sanofi Winthrop, Inc. 90 Park Avenue New York NY 10016 Generic Name: Procarbazine HCl Trade Name (if present): Matulane Date Designated 8/8/2006 Date Approved Designation Approved: Sponsor Contact Information Sigma-Tau Pharmaceuticals, Inc. 800 South Frederick Avenue Gaithersburg MD 20877 Generic Name: Progesterone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/22/1994 Date Approved Watson Laboratories, Inc. 311 Bonnie Circle Corona CA 91720 Generic Name: Propamidine isethionate 0.1% ophthalmic solution Trade Name (if present): Brolene Date Designated 3/10/1988 Date Approved Designation Approved: Sponsor Contact Information Bausch & Lomb Pharmaceuticals Division 8500 Hidden River Parkway Tampa FL 33637 Generic Name: Prostaglandin E1 enol ester (AS-013) Trade Name (if present): Circulase Date Designated 6/12/1998 Date Approved Designation Approved: Sponsor Contact Information LTT Baio-Pharma Co., Ltd Research & Development Division 2-5-1 Atago, Minato-ku, Tokyo JAPAN Generic Name: Prostaglandin E1 in lipid emulsion Trade Name (if present): Lipo-PGE1 Date Designated 9/10/1996 Date Approved Designation Approved: Sponsor Contact Information Alpha Therapeutic Corporation 5555 Valley Boulevard Los Angeles CA 90032 Generic Name: Protaxel Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/21/2003 Date Approved Biophysica, Inc. 2159 Avenida de la Playa Suite B La Jolla CA 92037 Generic Name: Protein C concentrate Trade Name (if present): Ceprotin Date Designated 6/23/1992 Date Approved 3/30/2007 Designation Approved: Prevention and treatment of venous thrombosis and purpura fulminans Sponsor Contact Information Baxter Healthcare Corporation One Baxter Way West Lake Village CA 91362 Generic Name: Protein C concentrate Trade Name (if present): Protein C Concentrate (human) Vapor Heated, Immuno Date Designated 4/22/1993 Date Approved Designation Approved: Sponsor Contact Information Immuno Clinical Research Corp. 750 Lexington Avenue, 19th Floor New York NY 10022 Generic Name: Protein C concentrate Trade Name (if present): Protein C Concentrate (human) Vapor Heated, Immuno Date Designated 6/19/1992 Date Approved Designation Approved: Sponsor Contact Information Immuno Clinical Research Corp. 750 Lexington Avenue, 19th Floor New York NY 10022 Generic Name: Protirelin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/24/1993 Date Approved UCB Pharma, Inc. 1950 Lake Park Drive Smyrna GA 30080 Generic Name: Protirelin injection Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/10/1985 Date Approved Abbott Laboratories 200 Abbott Park Road Abbott Park IL Generic Name: Pulmonary surfactant replacement Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/5/1988 Date Approved Scios Nova, Inc. 2450 Bayshore Parkway Mountain View CA 94043 Generic Name: Pulmonary surfactant replacement, porcine Trade Name (if present): Curosurf Date Designated 8/2/1993 Date Approved 1/1/9999 Designation Approved: Treatment (rescue) of respiratory distress syndrome in premature infants. Sponsor Contact Information Dey Laboratories 2751 Napa Valley Corporate Drive Napa CA 94558 Generic Name: Purified extract of Pseudomonas aeruginosa Trade Name (if present): ImmuDyn Date Designated 9/22/1997 Date Approved Designation Approved: Sponsor Contact Information Able Laboratories, Inc. 200 Highland Avenue Suite 30 Needham MA 02494 Generic Name: Purified type II collagen Trade Name (if present): Colloral Date Designated 2/9/1995 Date Approved Designation Approved: Sponsor Contact Information AutoImmune, Inc. 128 Spring Street Lexington MA 02421 Generic Name: Pyruvate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/21/2001 Date Approved Cellular Sciences, Inc 84 park Avenue P.O. Box 968 Flemington NJ 08822 Generic Name: Quinacrine hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/17/1984 Date Approved Lyphomed, Inc. Generic Name: quinine Sulfate Trade Name (if present): Designation Approved: Treatment of uncomplicated Plasmodium falciparum malaria Sponsor Contact Information Date Designated 6/3/2004 Date Approved 8/12/2005 AR Holding Company, Inc. 1100 Orthodox Street Philadelphia PA 19124 Generic Name: R-(-)-gossypol Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/24/2006 Date Approved Ascenta Therapeutics, Inc. 101 Lindenwood Drive Suite 405 Malvern PA 19355 Generic Name: rAAV2-CB-hRPE65 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/11/2005 Date Approved Applied Genetic Technologies Corp. 11801 Research Drive Suite D Alachua FL 32615 Generic Name: Rabbit anti-human thymocyte globulin (rATG) Trade Name (if present): Thymoglobulin Date Designated 9/26/2006 Date Approved Designation Approved: Sponsor Contact Information Children's Hospital of Pittsburgh University of Pittsburgh Pittsburgh PA 15213 Generic Name: Raloxifene Trade Name (if present): Evista Date Designated 7/14/2005 Date Approved 9/13/2007 Designation Approved: Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer Sponsor Contact Information Eli Lilly and Company Lilly Corporate Center Drop Code 1853 Indianapolis IN 46285 Generic Name: ranprinase Trade Name (if present): Onconase Date Designated 1/25/2007 Date Approved Designation Approved: Sponsor Contact Information Alfacell Corporation 225 Belleville Ave. Bloomfield NJ 07003 Generic Name: Rapamycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/20/2007 Date Approved OncoImmune, Inc. 1275 Kinnear Road Columbus OH 43212 Generic Name: Rapamycin (mTOR) inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/9/2005 Date Approved ARIAD Pharmaceuticals, Incx. 26 Landsdowne Street Cambridge MA 02139-4234 Generic Name: rasburicase Trade Name (if present): Elitek Date Designated 10/11/2000 Date Approved 7/12/2002 Designation Approved: Initial management of plasma uric acid levels in pediatric patients with leukemia,lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Sponsor Contact Information Sanofi-Synthelabo Research 9 Great Valley Parkway Malvern PA 19355 Generic Name: raxibacumab Trade Name (if present): Abthrax Date Designated 11/12/2003 Date Approved Designation Approved: Sponsor Contact Information Human Genome Sciences, Inc. 14200 Shady Grove Road Rockville MD 20850 Generic Name: recombinant adeno-associated virus alpha 1-antitrypsin vector Trade Name (if present): rAAV-AAT Date Designated 1/27/2003 Date Approved Designation Approved: Sponsor Contact Information Applied Genetic Technologies Corp. 12085 Research Drive Suite 110 Alachua FL 32615 Generic Name: Recombinant anti-CD22 immunotoxin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/15/2007 Date Approved Cambridge Antibody Technology, INc. 3260 Hillview Avenue Palo Alto CA 94304 Generic Name: Recombinant anti-CD22 immunotoxin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/15/2007 Date Approved Cambridge Antibody Technology, Inc. 3260 Hillview Avenue Palo Alto CA 94304 Generic Name: Recombinant anti-CD40 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/12/2005 Date Approved Novartis Pharmaceutical Corporation Oncology Business Unit One Health Plaza East Hanover NJ 07986 Generic Name: Recombinant anti-CD-40 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/25/2006 Date Approved Novartis Pharmaceutical Corporation Oncology Business Unit One Health Plaza East Hanover NJ 07936 Generic Name: Recombinant bactericidal/permeabilityincreasing protein Trade Name (if present): Neuprex Date Designated 6/22/1998 Date Approved Designation Approved: Sponsor Contact Information Xoma (US) LLC 2910 Seventh Street Berkeley CA 94710 Generic Name: recombinant chimeric monoclonal antibody to anthrax Trade Name (if present): Anthim Date Designated 6/9/2006 Date Approved Designation Approved: Sponsor Contact Information Elusys Therapeutics, Inc. 25 Riverside Drive P.O. Box 102 Pine Brook NJ 07058 Generic Name: Recombinant coagulation factor VIIa Trade Name (if present): Novoseven Date Designated 4/26/2006 Date Approved Designation Approved: Sponsor Contact Information PharmaOrigin ApS Agern Alle 3 2970 Horsholm DENMARK Generic Name: Recombinant deriative of C3 transferase Trade Name (if present): Cethrin Date Designated 11/18/2005 Date Approved Designation Approved: Sponsor Contact Information Alseres Pharmaceuticals, Inc. 85 Main Street Hopkinton MA 01748 Generic Name: Recombinant Epstein-Barr virus gp350 glycoprotein vaccine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/18/2005 Date Approved Henogen S.A. Rue des Professeurs Jenner et Brachet, 12 B-6041-Gosselies Generic Name: recombinant fusion protein with a truncated form of the cytotoxic protein Pseudomonas exotoxin Trade Name (if present): Proxinium Date Designated 1/28/2005 Date Approved Designation Approved: Sponsor Contact Information Viventia Biotech, Inc. 10 Four Seasons Place Toronto ON M9B 6H7 CANADA Generic Name: Recombinant glycine2-human glucagon-like peptide-2 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/29/2000 Date Approved NPS Allelix Corp. 6850 Goreway Dr. Mississauga CANADA Generic Name: Recombinant human acid alphaglucosidase Trade Name (if present): Myozyme Date Designated 8/19/1997 Date Approved 4/28/2006 Designation Approved: For use in patients with Pompe disease (GAA deficiency). Alglucosidase alfa has been shown to improve ventilator-free survival in patients with infantile onset Pompe disease as compared to an untreated historical control, whereas use of Alphaglucosidase in patients with other forms of Pompe disease has not been adequately studied to assure safety and Sponsor Contact Information Genzyme Corporation One Kendall Square Cambridge MA 02139 Generic Name: Recombinant human alpha 1-antitrypsin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/28/2005 Date Approved Arriva Pharmaceuticals, Inc. 1010 Atlantic Avenue Alameda CA 94501 Generic Name: recombinant human alpha 1-antitrypsin (rAAT) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/20/2001 Date Approved Arriva Pharmaceuticals, Inc. 2020 Challenger Drive Alameda CA 94501 Generic Name: recombinant human alpha-1 antitrypsin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/6/1998 Date Approved PPL Therapeutics (Scotland) Limited Roslin, Edinburgh EH259PP Scotland UNITED KINGDOM Generic Name: recombinant human alpha-1 antitrypsin (rAAT) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/28/2001 Date Approved Arriva Pharmaceuticals, Inc. 1010 Atlantic Avenue Alameda CA 94501 Generic Name: Recombinant Human Alpha-Fetoprotein (rhAFP) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/22/2001 Date Approved Merrimack Pharmaceuticals, Inc. 101 Binney Street Cambridge MA 02142 Generic Name: Recombinant human alpha-mannosidase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/2/2006 Date Approved Zymenex A/S Roskildevej 12 C DENMARK Generic Name: Recombinant human anti-GDF-8 (growth and differentiation factor-8) antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/16/2005 Date Approved Wyeth Pharmaceuticals, Inc. P. O. Box 8299 Philadelphia PA 19101-8299 Generic Name: Recombinant human antithrombin Trade Name (if present): ATryn Date Designated 12/7/2007 Date Approved Designation Approved: Sponsor Contact Information GTC Biotherapeutics, Inc. 175 Crossing Blvd Framingham MA 01702 Generic Name: Recombinant human antithrombin III Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/6/2000 Date Approved AT III LLC c/o Genzyme Corporation 15 Pleasant St. Connector, P.O. Box 9322 Framingham MA 01701 Generic Name: recombinant human arylsulphatase A Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/11/2008 Date Approved Zymenex A/S Roskildevej 12C 3400 Hillerod DENMARK Generic Name: Recombinant human C1 inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/9/2006 Date Approved Pharming Technologies B.V. Archimedesweg 4 NETHERLANDS Generic Name: Recombinant human C1 inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/9/2006 Date Approved Pharming Technologies B.V. Archimedesweg 4 NETHERLANDS Generic Name: Recombinant human C1-esterase inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/23/1999 Date Approved Pharming N.V. Cipalstreet 3 B-2440 Geel BELGIUM Generic Name: Recombinant human C1-esterase inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/23/1999 Date Approved Pharming N.V. Cipalstreet 3 B-2440 Geel BELGIUM Generic Name: Recombinant human CD4 immunoglobulin G Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/30/1990 Date Approved Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Recombinant human Clara Cell 10kDa protein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/13/1998 Date Approved CC10 Sweden AB Kornhamnstorg 53 Box 2077 SWEDEN Generic Name: Recombinant human endostatin protein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/13/2001 Date Approved EntreMed, Inc. 9640 Medical Center Drive Rockville MD 20850 Generic Name: recombinant human endostatin protein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/21/2002 Date Approved EntreMed, Inc. 9640 Medical Center Drive Rockville MD 20850 Generic Name: Recombinant human fibrinogen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/4/2007 Date Approved Pharming Technologies B.V. Archimedesweg 4 NETHERLANDS Generic Name: recombinant human fibroblast growth factor-20 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/29/2004 Date Approved CuraGen Corporation 322 East Main Street Branford CT 06405 Generic Name: Recombinant human gelsolin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/6/1995 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Recombinant human gelsolin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/12/1994 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02124 Generic Name: Recombinant human granulocyte colony stimulating factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/24/2006 Date Approved Nora, LLC 2400 Boston Street Baltimore MD 21224 Generic Name: Recombinant human highly phosphorylated acid alpha-glucosidase Trade Name (if present): TBD Date Designated 9/20/2000 Date Approved Designation Approved: Sponsor Contact Information Novazyme Pharmaceuticals, Inc. 800 Research Parkway Suite 200 Oklahoma City OK 73104 Generic Name: Recombinant human insulin-like growth factor 1 Trade Name (if present): IGF-1 Date Designated 6/7/1995 Date Approved Designation Approved: Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Kalamazoo MI 49001-0199 Generic Name: Recombinant human insulin-like growth factor 1 Trade Name (if present): IGF-1 Date Designated 6/7/1995 Date Approved Designation Approved: Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Kalamazoo MI 49001-0199 Generic Name: Recombinant human insulin-like growth factor-I Trade Name (if present): PV802 Date Designated 2/16/2000 Date Approved Designation Approved: Sponsor Contact Information GroPep Pty Ltd. Gate 11, Victoria Dr. Adelaide SA 5000 AUSTRALIA Generic Name: Recombinant human insulin-like growth factor-I Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/13/1995 Date Approved Cephalon, Inc. 41 Moores Road P. O. Box 4011 Frazer PA 19355 Generic Name: Recombinant human insulin-like growth factor-I/insulin-like growth factor binding protein-3 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/15/1999 Date Approved Insmed, Inc. P.O. Box 2400 Glen Allen VA 23058-2400 Generic Name: Recombinant human interleukin-12 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/20/1997 Date Approved Genetics Institute, Inc. 87 CambridgePark Drive Cambridge MA 02140 Generic Name: Recombinant Human Interleukin-21 (rIL-21) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/4/2005 Date Approved Zymo Genetics, Inc 1201 Eastlake Avenue East Seattle WA 98102 Generic Name: Recombinant human keratinocyte growth factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/20/1999 Date Approved Amgen Inc. One Amgen Center Dr. Thousand Oaks CA 91320-1799 Generic Name: Recombinant human luteinizing hormone Trade Name (if present): Luveris Date Designated 10/7/1994 Date Approved 10/8/2004 Designation Approved: Luveris (lutropin alfa for injection), concomitantly administered with Gonal-f (follitropin alfa for injection), is indicated for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH (less than) 1.2 IU/L). Sponsor Contact Information Serono Laboratories, Inc. One Technology Place Rockland MA 02370 Generic Name: Recombinant human lysosomal acid lipase or cholesteryl ester hydrolase Trade Name (if present): Cholestrase Date Designated 7/14/2005 Date Approved Designation Approved: Sponsor Contact Information Large Scale Biology Corporation 3333 Vaca Valley Parkway Vacaville CA 95688 Generic Name: Recombinant human microplasmin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/23/2006 Date Approved ThromboGenics Ltd Unit 14, Bridgecourt Office Park Dublin IRELAND Generic Name: recombinant human monoclonal antibody to hsp90 Trade Name (if present): Mycograb Date Designated 9/16/2002 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaceuticals Corp. One Health Plaza East Hanover NJ 07936-1080 UNITED KINGDOM Generic Name: Recombinant human nerve growth factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/16/1999 Date Approved Genentech, Inc. 1 DNA Way South San Francisco CA 94080 Generic Name: recombinant human neutrophil inhibitor (hNE) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/9/2003 Date Approved Dyax Corporation 300 Technology Square Cambridge MA 02139 Generic Name: Recombinant human platelet derived growth factor BB Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/2007 Date Approved Luitpold Pharmaceuticals, Inc. P. O. Box 9001 One Luitpold Drive Shirley NY 11967 Generic Name: recombinant human porphobilinogen deaminase Trade Name (if present): Porphozyme Date Designated 9/9/2002 Date Approved Designation Approved: Sponsor Contact Information Zymenex A/S Roskildevej 12C 3400 Hillerod DENMARK Generic Name: recombinant human porphobilinogen deaminase, erythropoetic form Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/11/2002 Date Approved ZymmenexA/S Roskildevej 12C 3400 Hillerod DENMARK Generic Name: Recombinant human relaxin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/3/1995 Date Approved Connetics Corporation 3400 West Bayshore Road Palo Alto CA 94303 Generic Name: recombinant human rod-derived cone viability factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/7/2008 Date Approved Fovea Pharmaceuticals 12 Rue Jean Antoine de Baif Paris FRANCE Generic Name: Recombinant human thrombopoietin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/29/1997 Date Approved Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: Recombinant humanized MAb 5c8 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/22/1999 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Recombinant humanized MAb 5c8 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/22/1999 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Recombinant humanized MAb 5c8 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/14/1998 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Recombinant humanized monclonal antibody 5c8 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/3/1998 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Recombinant humanized monoclonal antibody 5c8 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/18/1998 Date Approved Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: recombinant inhibitor of human plasma kallikrein Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/4/2003 Date Approved Dyax Corp 300 Technology Square Cambridge MA 02139 Generic Name: Recombinant methionyl brain-derived neurotrophic factor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/28/1994 Date Approved Amgen, Inc. One Amgen Center Dr. Thousand Oaks CA 91320-1799 Generic Name: recombinant ovine interferon tau Trade Name (if present): Tauferon Date Designated 1/25/2005 Date Approved Designation Approved: Sponsor Contact Information PEPGEN Corporation 1301 Harbor Bay Parkway Alameda CA 94502 Generic Name: Recombinant Porcine Factor VIII, B-domain Deleted Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/16/2004 Date Approved Ipsen Limited 190 Bath Road Berkshire S11 3XE UNITED KINGDOM Generic Name: Recombinant P-Selectin glycoprotein ligand Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/29/2006 Date Approved Y's Therapeutics, Inc. 866 Malcolm Road Burlingame CA 94010 Generic Name: Recombinant P-selectin glycoprotein ligand-immunoglobulin Ig Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/26/2007 Date Approved Y's Therapeutics, Inc. 866 Malcolm Road Burlingame CA 94010 Generic Name: Recombinant retroviral vector glucocerebrosidase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/15/1993 Date Approved Genetic Therapy, Inc. 938 Clopper Road Gaithersburg MD 20878 Generic Name: Recombinant secretory leucocyte protease inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/29/1991 Date Approved Amgen, Inc. 3200 Walnut Street Boulder CO 80301 Generic Name: Recombinant secretory leucocyte protease inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/29/1991 Date Approved Amgen Inc. 3200 Walnut Street Boulder CO 80301 Generic Name: Recombinant soluble human CD4 Trade Name (if present): Receptin Date Designated 11/20/1989 Date Approved Designation Approved: Sponsor Contact Information Biogen, Inc. 14 Cambridge Center Cambridge MA 02142 Generic Name: Recombinant soluble human CD4 (rCD4) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/23/1989 Date Approved Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Recombinant T-cell receptor ligand Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/2/2003 Date Approved Artielle ImmunoTherapeutics, Inc. 9020 SW Washington Square Road Suite 380 Tigard, OR 97223-4332 Generic Name: Recombinant truncated SPINT2 protease inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/24/2005 Date Approved Aerovance, Inc. 2929 Seventh Street Berkeley CA 94710 Generic Name: Recombinant urate oxidase Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/2000 Date Approved Sanofi-Synthelabo Research 9 Great Valley Parkway Malvern PA 19355 Generic Name: Reduced L-glutathione Trade Name (if present): Cachexon Date Designated 2/14/1994 Date Approved Designation Approved: Sponsor Contact Information Telluride Pharmaceutical Corporation 146 Flanders Drive Hillsborough NJ 08876 Generic Name: Remacemide Trade Name (if present): Ecovia Date Designated 3/6/2000 Date Approved Designation Approved: Sponsor Contact Information AstraZeneca LP 725 Chesterbrook Blvd. Wayne PA 19087-5677 Generic Name: Reparixin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/27/2003 Date Approved Dompe s.p.a. Via Campo di Pile 67100 - L'Aquila ITALY Generic Name: repository corticotropin or adrenocorticotropic hormone Trade Name (if present): H.P. Acthar Gel Date Designated 5/21/2003 Date Approved Designation Approved: Sponsor Contact Information Questcor Pharmaceuticals, Inc. 3260 Whipple Road Union City CA 94587-1217 Generic Name: resiniferatoxin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/13/2003 Date Approved NIH/NIDCR Bldg 10/Rm 2N236 - DASS/CC 10 Convent Drive Bethesda MD 20892 Generic Name: Reslizumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/19/2007 Date Approved Ception Therapeutics, Inc. 101 Lindenwood Drive Suite 400, Valleybrook III Malvern PA 19335 Generic Name: Respiratory Syncytial Virus Immune Globulin (human) Trade Name (if present): Hypermune RSV Date Designated 9/27/1990 Date Approved Designation Approved: Sponsor Contact Information MedImmune, Inc. 35 West Watkins Mill Road Gaithersburg MD 20878 Generic Name: Respiratory syncytial virus immune globulin (Human) Trade Name (if present): Respigam Date Designated 9/27/1990 Date Approved 1/18/1996 Designation Approved: For the prevention of serious lower respiratory tract infections caused by RSV in children less than 24 months of age with bronchopulmonary dysplasia or a history of prematurity (less than or equal to 35 weeks gestation). Sponsor Contact Information MedImmune & Massachussetts Public Health Biologics Labs. 35 West Watkins Mill Road Gaithersburg MD 20878 Generic Name: R-etodolac Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/9/2002 Date Approved Cephalon, Inc. 41 Moores Road Frazer PA 19355 Generic Name: retroviral gamma-c cDNA containing vector Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/29/2002 Date Approved AVAX technologies, Inc. 9200 Indian Creek Parkway Building 9, Suite 200 Overland Park KS 66210 Generic Name: Retroviral vector, R-GC and GC gene 1750 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/6/1997 Date Approved Genzyme Corporation One Mountain Road P.O. Box 9322 Framingham MA 01701-9322 Generic Name: Reviparin sodium Trade Name (if present): Clivarine Date Designated 6/18/2001 Date Approved Designation Approved: Sponsor Contact Information Abbott Abbott Laboratories, Dept. 389, Bldg. J-45 200 Abbott Park Rd. Abbott Park IL 60064-6135 Generic Name: Reviparin sodium Trade Name (if present): Clivarine Date Designated 6/18/2001 Date Approved Designation Approved: Sponsor Contact Information Abbott Abbott Laboratories, Dept. 389, Bldg. J-45 200 Abbott Park Rd. Abbott Park IL 60064-6133 Generic Name: RGG0853, E1A lipid complex Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/15/1995 Date Approved Targeted Genetics Corporation 1100 Olive Way, Suite 100 Seattle WA 98101 Generic Name: rhIGF-I/rhIGFBP-3 Trade Name (if present): SomatoKine Date Designated 12/9/2003 Date Approved Designation Approved: Sponsor Contact Information Insmed Inc. 4851 Lake Brooke Drive Glen Allen VA 23060 Generic Name: rh-microplasmin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/16/2004 Date Approved ThromboGenics Inc. Unit 14 Walkinstown Avenue Dublin 12 IRELAND Generic Name: Rho (D) immune globulin intravenous (human) Trade Name (if present): WinRho SD Date Designated 11/9/1993 Date Approved 3/24/1995 Designation Approved: Treatment of adults and children with chronic and acute immune thrombocytopenic purpura. Sponsor Contact Information Rh Pharmaceuticals, Inc. 104 Chancellor Matheson Road Winnipeg, Manitoba CANADA Generic Name: Ribavirin Trade Name (if present): Virazole Date Designated 4/12/1991 Date Approved Designation Approved: Sponsor Contact Information Valeant Pharmaceuticals International 3300 Hyland Avenue Costa Mesa CA 92626 Generic Name: ribavirin Trade Name (if present): REBETOL Date Designated 4/4/2003 Date Approved 7/29/2003 Designation Approved: Treatment of chronic hepatitis C among previously untreated pediatric patients at least three years of age or older. Sponsor Contact Information Schering Corporation 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Ricin (blocked) conjugated murine mca (anti-b4) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/24/1991 Date Approved ImmunoGen, Inc. 148 Sidney Street Cambridge MA 02139 Generic Name: Ricin (blocked) conjugated murine MCA (anti-B4) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/17/1988 Date Approved ImmunoGen, Inc. 148 Sidney Street Cambridge MA 02139 Generic Name: Ricin (blocked) conjugated murine MCA (anti-my9) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/1989 Date Approved ImmunoGen, Inc. 148 Sidney Street Cambridge MA 02139 Generic Name: Ricin (blocked) conjugated murine MCA (anti-my9) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/1990 Date Approved ImmunoGen, Inc. 148 Sidney Street Cambridge MA 02139 Generic Name: Ricin (blocked) conjugated murine MCA (n901) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/25/1991 Date Approved ImmunoGen, Inc. 148 Sidney Street Cambridge MA 02139 Generic Name: Ricin (blocked) conjugated murine monoclonal antibody (CD6) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/6/1994 Date Approved ImmunoGen, Inc. 148 Sidney Street Cambridge MA 02139 Generic Name: Rifabutin Trade Name (if present): Mycobutin Date Designated 12/18/1989 Date Approved 12/23/1992 Designation Approved: Prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infections. Sponsor Contact Information Adria Laboratories, Inc. P.O. Box 16529 Columbus OH 43216 Generic Name: Rifabutin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/1989 Date Approved Pfizer, Inc. 235 East 42nd Street New York NY 10017 Generic Name: Rifalazil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/13/1999 Date Approved PathoGenesis Corporation 201 Elliott Avenue West Suite 150 Seattle WA 98119 Generic Name: Rifampin Trade Name (if present): Rifadin I.V. Date Designated 12/9/1985 Date Approved 5/25/1989 Designation Approved: Sponsor Contact Information Hoechst Marion Roussel P.O. Box 9627 Kansas City MO 64134 Generic Name: Rifampin, isoniazid, pyrazinamide Trade Name (if present): Rifater Date Designated 9/12/1985 Date Approved 5/31/1994 Designation Approved: Short-course treatment of tuberculosis. Sponsor Contact Information Hoechst Marion Roussel P.O. Box 9627 Kansas City MO 64134 Generic Name: Rifapentine Trade Name (if present): Priftin Date Designated 3/12/1996 Date Approved Designation Approved: Sponsor Contact Information Hoechst Marion Roussel, Inc. P.O. Box 9627 Mail Station: H3-M2516 Kansas City MO 64134-0627 Generic Name: Rifapentine Trade Name (if present): Priftin Date Designated 6/9/1995 Date Approved Designation Approved: Sponsor Contact Information Hoechst Marion Roussel , Inc. P.O. Box 9627 Mail Station: H3-M2516 Kansas City MO 64134-0627 Generic Name: Rifapentine Trade Name (if present): Priftin Date Designated 6/9/1995 Date Approved 6/22/1998 Designation Approved: Sponsor Contact Information Hoechst Marion Roussel P.O. Box 9627 Mail Station: H3-M2516 Kansas City MO 64134-0627 Generic Name: Rifaximin Trade Name (if present): Normix Date Designated 2/10/1998 Date Approved Designation Approved: Sponsor Contact Information Salix Pharmaceuticals, Inc. 1700 Perimeter Park Drive Morrisville NC 27560 Generic Name: RII retinamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/6/1993 Date Approved Sparta Pharmaceuticals, Inc. 111 Rock Road Horsham PA 19044-2310 Generic Name: Rilonacept Trade Name (if present): Arcalyst Date Designated 12/20/2004 Date Approved 2/27/2008 Designation Approved: Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS) Sponsor Contact Information Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown NY 10591 Generic Name: Riluzole Trade Name (if present): Rilutek Date Designated 10/15/1996 Date Approved Designation Approved: Sponsor Contact Information Rhone-Poulenc Rorer Pharmaceuticals, Inc. 500 Arcola Road PO Box 5096 Collegeville PA 19426-0800 Generic Name: Riluzole Trade Name (if present): Rilutek Date Designated 3/16/1993 Date Approved 12/12/1995 Designation Approved: Treatment of patients with amyotrophic lateral sclerosis. Riluzole extends survival and/or time to tracheostomy. Sponsor Contact Information Rhone-Poulenc Rorer Pharmaceuticals, Inc. 500 Arcola Road, P.O. Box 1200 Collegeville PA 19426 Generic Name: risedronate sodium Trade Name (if present): Actonel Date Designated 12/18/2006 Date Approved Designation Approved: Sponsor Contact Information Proctor and Gamble Pharmaceuticals 8700 Mason-Montgomery Road Mason OH 08807 Generic Name: rituximab Trade Name (if present): Rituxan Date Designated 2/14/2006 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: rituximab Trade Name (if present): Rituxan Date Designated 3/12/2002 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: rituximab Trade Name (if present): Rituxan Date Designated 6/13/1994 Date Approved 11/26/1997 Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way, MS 242 South San Francisco CA 94080-4990 Generic Name: rituximab Trade Name (if present): Rituxan Date Designated 1/29/2004 Date Approved Designation Approved: Sponsor Contact Information Biogen IDEC, Inc. 5200 Research Place San Diego CA 92122 Generic Name: RNA, ((2',3'-dideoxy-2',3'-imino-2',3'seco)[dimethylamino)phosphinylideneoxy] (2'a-5') (CTC CAA CAT CAA GGA AGATGG CAT TTC TAG)), P-[4-[[2-[2-(2hydroxyethoxy)ethoxy]ethoxy]carbonyl]-1piperazinyl]-N,Ndimethylaminophosphonamidate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/23/2007 Date Approved AVI BioPharma, Inc. One SW Columbia Street Portland OR 97258 Generic Name: rofecoxib Trade Name (if present): Vioxx Date Designated 3/16/2004 Date Approved Designation Approved: Sponsor Contact Information MERCK & Co., Inc. 126 East Lincoln Ave. Rahway NJ 07065 Generic Name: rolespimycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/31/2007 Date Approved Infinity Pharmaceuticals, Inc. 780 Memorial Drive Cambridge MA 02139 Generic Name: romidepsin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/30/2004 Date Approved Gloucester Pharmaceuticals, Inc. One Broadway Cambridge MA 02142 Generic Name: Roquinimex Trade Name (if present): Linomide Date Designated 7/1/1993 Date Approved Designation Approved: Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Kalamazoo MI 49001-0199 Generic Name: Rose Bengal Disodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/20/2006 Date Approved Provectus Pharmaceuticals, Inc. 7327 Oak Ridge Highway Knoxville TN 37931 Generic Name: rSP-C lung surfactant Trade Name (if present): Venticute Date Designated 4/3/2000 Date Approved Designation Approved: Sponsor Contact Information Byk Gulden Pharmaceuticals Byk-Gulden StraBe 2 78467 Konstanz GERMANY Generic Name: rSP-C surfactant Trade Name (if present): Venticute Date Designated 9/18/2006 Date Approved Designation Approved: Sponsor Contact Information Altana Pharma 220 Park avenue Florham Park NJ 07932 Generic Name: rubitecan Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/17/2002 Date Approved SuperGen, Inc. 4140 Dublin Blvd. Suite 200 Dublin CA 94568 Generic Name: Rufinamide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/8/2004 Date Approved Eisai Medical Research, Inc. 55 Challenger Road Ridgefield NJ 07660 Generic Name: S(-)-3-[3-amino-phthalimido]-glutaramide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/14/2002 Date Approved EntreMed Incorporated 9640 Medical Center Dr. Rockville MD 20850 Generic Name: Sacrosidase Trade Name (if present): Sucraid Date Designated 12/10/1993 Date Approved 4/9/1998 Designation Approved: Oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrease-isomaltase deficiency. Sponsor Contact Information QOL Medical, LLC 12419 198th Drive, NE Woodinville WA 98072 Generic Name: S-adenosylmethionine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/30/1998 Date Approved Genopia USA, Inc. 90 Gold Street, 6N New York NY 10038 Generic Name: salirasib Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2006 Date Approved Concordia Pharmaceuticals, Inc. 1550 Sawgrass Corporate Parkway Sunrise FL 33323 Generic Name: sapropterin Trade Name (if present): Kuvan Date Designated 1/29/2004 Date Approved 12/13/2007 Designation Approved: Indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Pherestricted diet. Sponsor Contact Information Biomarin Pharmaceutical Inc. 371 Bel Marin Blvd. Novato CA 94949 Generic Name: Sargramostim Trade Name (if present): Leukine Date Designated 5/3/1990 Date Approved 3/5/1991 Designation Approved: Sponsor Contact Information Immunex Corporation 51 University Street Seattle WA 98101 Generic Name: Sargramostim Trade Name (if present): Leukine Date Designated 3/6/1995 Date Approved 9/15/1995 Designation Approved: Following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. Sponsor Contact Information Immunex Corporation 51 University Street Seattle WA 98101 Generic Name: sarsasapogenin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/18/2004 Date Approved Phytopharm plc Corpus Christi House Godmanchester, Cambridgeshire PE29 2HY UNITED KINGDOM Generic Name: Satumomab pendetide Trade Name (if present): Oncoscint CR/OV Date Designated 9/25/1989 Date Approved 12/29/1992 Designation Approved: For determining the extent and location of extraphepatic malignant disease in patients with known colorectal and ovarian cancer. Sponsor Contact Information Cytogen Corporation 600 College Road East Princeton NJ 08540 Generic Name: SB-408075 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/7/2000 Date Approved SmithKline Beecham Pharmaceuticals 1250 S. Collegeville Road Collegeville PA 19426-0989 Generic Name: SC-1 monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/12/2003 Date Approved Debiovision Inc. 666 Sherbrooke Street West, Suite 1400 Montreal, Quebec Generic Name: SCH 58500 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/12/1999 Date Approved Schering Corporation 2000 Galloping Hill Rd. Kenilworth NJ 07033 Generic Name: SDF-1 (108) Lysine Dlmer Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/7/2005 Date Approved Chemokine Therapeutics Corporation 190 Agronomy Road (UBC) Suite 405 Vancouver, BC V6T 1Z3 CANADA Generic Name: Secalciferol Trade Name (if present): Osteo-D Date Designated 7/26/1993 Date Approved Designation Approved: Sponsor Contact Information Teva Pharmaceuticals USA 650 Cathill Rd. Sellersville PA 18960 Generic Name: Secretory leukocyte protease inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/30/1992 Date Approved Synergen, Inc. 1885 33rd Street Boulder CO 80301 Generic Name: Selegiline HCl Trade Name (if present): Eldepryl Date Designated 11/7/1984 Date Approved 6/5/1989 Designation Approved: Sponsor Contact Information Somerset Pharmaceuticals, Inc. 777 South Harbor Island Boulevard Tampa FL 33602 Generic Name: Sermorelin acetate Trade Name (if present): Geref Date Designated 9/14/1988 Date Approved 9/26/1997 Designation Approved: Sponsor Contact Information Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Sermorelin acetate Trade Name (if present): Geref Date Designated 2/13/1990 Date Approved Designation Approved: Sponsor Contact Information EMD Serono, Inc. One Technology Place Rockland MA 02370 Generic Name: Sermorelin acetate Trade Name (if present): Geref Date Designated 12/5/1991 Date Approved Designation Approved: Sponsor Contact Information EMD Serono, Inc. One Technology Place Rockland MA 02370 Generic Name: Serratia marcescens extract (polyribosomes) Trade Name (if present): Imuvert Date Designated 9/7/1988 Date Approved Designation Approved: Sponsor Contact Information Cell Technology, Inc. 1668 Valtec Lane Boulder CO 80306 Generic Name: SGN-30 (anti-CD30 antibody) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/18/2004 Date Approved Seattle Genetics, Inc. 21823 30th Drive Southeast Bothell WA 98021 Generic Name: SGN-30 (anti-CD30 mAb) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/18/2003 Date Approved Seattle Genetics, Inc 21823 30th Drive, Southeast Bothell WA 98021 Generic Name: SGN-40 (anti-CD40 antibody) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/13/2004 Date Approved Seattle Genetics, Inc. 21823 30th Drive Southeast Bothell WA 98021 Generic Name: Short chain fatty acid enema Trade Name (if present): Colomed Date Designated 8/19/1997 Date Approved Designation Approved: Sponsor Contact Information Richard I. Breuer, M.D. 1000 Central Street, Suite 615 Evanston IL 60201 Generic Name: Short chain fatty acid solution Trade Name (if present): Colomed Date Designated 5/29/1990 Date Approved Designation Approved: Sponsor Contact Information Richard I. Breuer 1000 Central Street, Suite 615 Evanston IL 60201 Generic Name: Silver sulfadiazine and cerium nitrate Trade Name (if present): Flammacerium Date Designated 11/17/1999 Date Approved Designation Approved: Sponsor Contact Information Synthes (USA) 1690 Russell Road PO Box 1766 Paoli PA 19301 Generic Name: siplizumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/15/2003 Date Approved MedImmune, LLC One MedImmune Way Gaithersburg 20878 Generic Name: Sitaxsentan Sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/2/2004 Date Approved Encysive, L.P. 6700 West Loop South Suite 400 Bellaire TX 77401 Generic Name: SK&F 110679 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/23/1990 Date Approved SmithKline Beecham Pharmaceuticals One Franklin Plaza Philadelphia PA 19101 Generic Name: Sodium aluminosilicate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/4/2005 Date Approved Framework Therapeutics, LLc 1564 33rd Street, NW Washington DC 20007 Generic Name: Sodium ascorbate and menadione sodium bisulfite Trade Name (if present): Apatone Date Designated 7/31/2007 Date Approved Designation Approved: Sponsor Contact Information IC-MedTech Corporation 9902 Indian Creek Lane El Cajon CA 92021 Generic Name: Sodium dichloroacetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/11/1990 Date Approved Stacpoole, Peter W. M.D., Ph.D. University of Florida P.O. Box 100277 Gainesville FL 32610 Generic Name: Sodium dichloroacetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/11/1990 Date Approved Stacpoole, Peter W. M.D., Ph.D. University of Florida P.O. Box 100277 Gainesville FL 32610 Generic Name: Sodium dichloroacetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/31/1997 Date Approved Questcor Pharmaceuticals, Inc. 3260 Whipple Rd. Union City CA 94587-1217 Generic Name: Sodium dichloroacetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/10/1994 Date Approved Stacpoole, Peter W. M.D., Ph.D. University Of Florida P.O. Box 100277 Gainesville FL 32610 Generic Name: sodium dichloroacetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/3/2003 Date Approved EBD Group 2032 Corte del Nogal Suite 120 Carlsbad CA 92011 Generic Name: Sodium dichloroacetate Trade Name (if present): Ceresine Date Designated 6/14/1999 Date Approved Designation Approved: Sponsor Contact Information Questcor Pharmaceuticals, Inc. 3260 Whipple Rd. Union City CA 94587-0700 Generic Name: Sodium Monomercaptoundecahydro-closododecaborate Trade Name (if present): Borocell Date Designated 4/15/1992 Date Approved Designation Approved: Sponsor Contact Information Neutron Technology Corp.& Neutron R&D Partner 877 Main Street, Suite 402 Boise ID 83702 Generic Name: Sodium monomercaptoundecahydrocloso-dodecaborate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/1984 Date Approved Theragenics Corporation Generic Name: Sodium nitrite Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/2/2007 Date Approved Hope Pharmaceuticals, Inc 8260 E. Gelding Drive #104 Scottsdale AZ 85260 Generic Name: Sodium nitrite Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/18/2007 Date Approved Hope Pharmaceuticals 8260 East Gelding Drive Scottsdale AZ 85260 Generic Name: Sodium nitrite Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/17/2007 Date Approved Hope Pharmaceuticals 8260 E. Gelding Drive Scottsdale AZ 85260 Generic Name: Sodium nitrite and sodium thiosulfate Trade Name (if present): Cyanide Antidote Kit Date Designated 4/9/2008 Date Approved Designation Approved: Sponsor Contact Information Hope Pharmaceuticals 8260 E. Gelding Drive Scottsdale AZ 85260 Generic Name: Sodium nitrite/sodium thiosulfate Trade Name (if present): Cyanide Antidote Package Date Designated 3/23/2007 Date Approved Designation Approved: Sponsor Contact Information Keystone Pharmaceuticals, Inc. 26072 Merit Circle Laguna Hills CA 92653 Generic Name: Sodium phenylacetate/sodium benzoate 10%/10% Injection Trade Name (if present): Ammonul Date Designated 6/3/2005 Date Approved Designation Approved: Sponsor Contact Information Ucyclyd Pharma, Inc. 8125 North Hayden Road Scottsdaale AZ 85258 Generic Name: Sodium phenylbutyrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/20/2007 Date Approved Tikvah Therapeutics, Inc. 75 5th Street, NW. Atlanta GA 30308 Generic Name: Sodium phenylbutyrate Trade Name (if present): Buphenyl Date Designated 1/25/2007 Date Approved Designation Approved: Sponsor Contact Information Ucyclyd Pharma, Inc. 8125 N. Hayden Road Scottsdale AZ 85258 Generic Name: Sodium phenylbutyrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/24/1998 Date Approved Elan Drug Delivery, Inc. 1300 Gould Dr. Gainesville GA 30504 Generic Name: sodium phenylbutyrate Trade Name (if present): Buphenyl Date Designated 11/22/1993 Date Approved 4/30/1996 Designation Approved: Adjunctive therapy in the chronic managment of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase. Sponsor Contact Information Medicis Pharmaceutical Corp. 8125 N. Hayden Road Scottsdale AZ 85258 Generic Name: sodium phenylbutyrate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/2/1992 Date Approved Medicis Pharmaceutical Corp. 8125 N. Hayden Road Scottsdale AZ 85258 Generic Name: Sodium pyruvate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/31/2003 Date Approved Cellular Sciences, Inc. 84 Park Avenue P. O. Box 968 Flemington NJ 08822 Generic Name: Sodium stibogluconate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/16/2006 Date Approved Surgeon General of the US Army Commander, Us Army Medical Materiel Dev. Activity Ft. Detrick MD 21702 Generic Name: Sodium thiosulfate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/17/2004 Date Approved Adherex Technologies, Inc. 4620 Creekstone Drive Suite 200 Durham NC 27703 Generic Name: Sodium thiosulfate and sodium nitrite Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/2006 Date Approved Akorn, Inc. 2500 Millbrook Drive Buffalo Grove IL 60089 Generic Name: Sodium thiosulfate, sodium nitrite, amyl nitrite Trade Name (if present): Cyanide Antidote Package Date Designated 6/16/2006 Date Approved Designation Approved: Sponsor Contact Information Keystone Pharmaceuticals, Inc. 26072 Merit Circle Laguna Hills CA 92653 Generic Name: Solasonine and solamargine Trade Name (if present): Coramsine Date Designated 11/2/2005 Date Approved Designation Approved: Sponsor Contact Information Solbec Pharmaceuticals Limited P. O. Box 2142 WA 6018 AUSTRALIA Generic Name: Solasonine and solamargine Trade Name (if present): Coramsine Date Designated 2/6/2006 Date Approved Designation Approved: Sponsor Contact Information Solbec Pharmaceuticals Limited P. O. Box 2142 Osbourne Park, Western Australia 6017 AUSTRALIA Generic Name: Soluble complement receptor type 1 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/6/2000 Date Approved Avant Immunotherapeutics, Inc. 119 Fourth Ave. Needham MA 02494-2725 Generic Name: Soluble recombinant human complement receptor type 1 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/21/1994 Date Approved T Cell Sciences, Inc. 119 Fourth Avenue Needham Heights MA 02194 Generic Name: Solvent/detergent treated non-blood group specific human coagulation active plasma Trade Name (if present): UNIPLAS Date Designated 12/12/2005 Date Approved Designation Approved: Sponsor Contact Information Octapharma USA, Inc. 121 River Street 12th Floor Hoboken NJ 07030 Generic Name: Somatostatin Trade Name (if present): Zecnil Date Designated 6/20/1988 Date Approved Designation Approved: Sponsor Contact Information Ferring Laboratories, Inc. 400 Rella Boulevard, Suite 201 Suffern NY 10901 Generic Name: Somatostatin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/22/1994 Date Approved UCB, Inc. 1950 Lake Park Drive Smyrna GA 30080 Generic Name: Somatrem for injection Trade Name (if present): Protropin Date Designated 12/9/1985 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Somatrem for injection Trade Name (if present): Protropin Date Designated 12/9/1985 Date Approved 10/17/1985 Designation Approved: Sponsor Contact Information Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Somatropin Trade Name (if present): Humatrope Date Designated 12/15/2005 Date Approved Designation Approved: Sponsor Contact Information Eli Lilly and Company Lilly Corporate Center Indianapolis IN 46285 Generic Name: Somatropin Trade Name (if present): Norditropin Date Designated 8/9/2006 Date Approved 5/31/2007 Designation Approved: Treatment of short stature in patients with Noonan syndrome Sponsor Contact Information Novo Nordisk Inc. 100 College Road West Princeton NJ 08540 Generic Name: Somatropin Trade Name (if present): Norditropin Date Designated 11/5/1987 Date Approved Designation Approved: Sponsor Contact Information Novo Nordisk Pharmaceuticals 100 Overlook Center Suite 200 Princeton NJ 08540 Generic Name: Somatropin Trade Name (if present): Humatrope Date Designated 5/8/1990 Date Approved 12/30/1996 Designation Approved: Treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed. Sponsor Contact Information Eli Lilly and Company Lilly Corporate Center Indianapolis IN 46285 Generic Name: Somatropin Trade Name (if present): Norditropin Date Designated 9/1/1987 Date Approved Designation Approved: Sponsor Contact Information Novo Nordisk Pharmaceuticals 100 Overlook Center Suite 200 Princeton NJ 08540 Generic Name: Somatropin Trade Name (if present): Biotropin Date Designated 2/12/1993 Date Approved Designation Approved: Sponsor Contact Information Bio-Technology General Corp. 70 Wood Avenue, South Iselin NJ 08830 Generic Name: Somatropin Trade Name (if present): Genotropin Date Designated 9/6/1994 Date Approved 10/31/1997 Designation Approved: Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Road Kalamazoo MI 49001-0199 Generic Name: Somatropin Trade Name (if present): Serostim Date Designated 3/16/2004 Date Approved Designation Approved: Sponsor Contact Information Serono, Inc. One Technology Place Rockland MA 02370 Generic Name: Somatropin Trade Name (if present): Nutropin Date Designated 3/6/1987 Date Approved 10/17/1985 Designation Approved: Sponsor Contact Information Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Somatropin (rDNA) Trade Name (if present): Saizen Date Designated 5/3/1989 Date Approved Designation Approved: Sponsor Contact Information EMD Serono, Inc. One Technology Place Rockland MA 02370 Generic Name: Somatropin (rDNA origin) Trade Name (if present): Saizen Date Designated 3/6/1987 Date Approved 1/1/9999 Designation Approved: Long term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. Sponsor Contact Information Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Somatropin (rDNA origin) Trade Name (if present): Nutropin Depot Date Designated 10/28/1999 Date Approved 1/1/9999 Designation Approved: Long-term treatment of growth failure due to a lack of adequate endogenous growth hormone secetion for once- or twice-a-month administration. Sponsor Contact Information Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: Somatropin (rDNA origin) injection Trade Name (if present): Norditropin Date Designated 7/10/1987 Date Approved 1/1/9999 Designation Approved: Long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone. Sponsor Contact Information Novo Nordisk Pharmaceuticals 100 Overlook Center Suite 200 Princeton NJ 08540 Generic Name: Somatropin (r-DNA) Trade Name (if present): Zorbtive Date Designated 3/6/1995 Date Approved 12/1/2003 Designation Approved: Treatment of short bowel syndrome in patients receiving specialized nutritional support Sponsor Contact Information Serono Laboratories, Inc. One Technology Place Roackland MA 02370 Generic Name: Somatropin (r-DNA) for injection Trade Name (if present): Serostim Date Designated 3/26/1996 Date Approved Designation Approved: Sponsor Contact Information Serono Laboratories, Inc. One Technology Place Rockland MA 02370 Generic Name: Somatropin [rDNA] Trade Name (if present): Genotropin Date Designated 7/6/1999 Date Approved 6/20/2000 Designation Approved: Long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). Sponsor Contact Information Pharmacia & Upjohn 7000 Portage Rd. 0633-298-113 Kalamazoo MI 49001-0199 Generic Name: somatropin [rDNA] Trade Name (if present): Genotropin Date Designated 12/27/2000 Date Approved 7/25/2001 Designation Approved: For long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by two years of age. Sponsor Contact Information Pharmacia and Upjohn Company 7000 Portage Road Kalamazoo MI 49001 Generic Name: Somatropin for injection Trade Name (if present): Humatrope Date Designated 6/12/1986 Date Approved 3/8/1987 Designation Approved: Sponsor Contact Information Eli Lilly and Company Lilly Corporate Center Indianapolis IN 46285 Generic Name: Somatropin for injection Trade Name (if present): Nutropin Date Designated 11/18/1996 Date Approved 12/15/1997 Designation Approved: Sponsor Contact Information Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Somatropin for injection Trade Name (if present): Nutropin Date Designated 8/4/1989 Date Approved 11/17/1993 Designation Approved: Treatment of children with growth failure associated with chronic renal insufficency. Sponsor Contact Information Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Somatropin for injection Trade Name (if present): Serostim Date Designated 11/15/1991 Date Approved 8/23/1996 Designation Approved: Treatment of AIDS wasting or cachexia. Sponsor Contact Information Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Somatropin for injection Trade Name (if present): Nutropin Date Designated 3/23/1989 Date Approved 12/30/1996 Designation Approved: Treatment of growth failure associated with Turner syndrome. Sponsor Contact Information Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080 Generic Name: Sorafenib Trade Name (if present): Nexavar Date Designated 4/20/2006 Date Approved 3/24/2008 Designation Approved: Treatment of unresectable hepatocellular carcinoma Sponsor Contact Information Bayer Pharmaceuticals Corporation 400 Morgan Lane West Haven CT 06516 Generic Name: Sorafenib Trade Name (if present): Nexavar Date Designated 9/29/2006 Date Approved Designation Approved: Sponsor Contact Information Bayer Pharmaceuticals Corp. 400 Morgan Lane New Haven CT 06516 Generic Name: Sorafenib Trade Name (if present): Nexavar Date Designated 10/8/2004 Date Approved 12/20/2005 Designation Approved: Treatment of patients with advanced renal cell carcinoma Sponsor Contact Information Bayer Pharmaceutical Corporation 400 Morgan Lane West Haven CT 06516 Generic Name: Sorivudine Trade Name (if present): BRAVAVIR Date Designated 11/9/1995 Date Approved Designation Approved: Sponsor Contact Information Bristol-Myers Squibb 5 Research Parkway P.O. Box 5100 Wallingford CT 06492 Generic Name: Sotalol HCl Trade Name (if present): Betapace Date Designated 9/23/1988 Date Approved Designation Approved: Sponsor Contact Information Berlex Laboratories, Inc. 300 Fairfield Road Wayne NJ 07470 Generic Name: Sotalol HCl Trade Name (if present): Betapace Date Designated 9/23/1988 Date Approved 10/30/1992 Designation Approved: Sponsor Contact Information Berlex Laboratories, Inc. 300 Fairfield Road Wayne NJ 07470 Generic Name: spherical carbon adsorbent Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/19/2007 Date Approved Ocera Therapeutics, Inc. 12651 High Bluff Drive San Diego CA 92130 Generic Name: Spiramycin Trade Name (if present): Rovamycine Date Designated 10/17/1984 Date Approved Designation Approved: Sponsor Contact Information Rhone-Poulenc Rorer Pharmaceuticals 500 Arcola Road Collegeville PA 19426 Generic Name: squalamine lactate Trade Name (if present): Designation Approved: Treatment of ovarian cancer Sponsor Contact Information Date Designated 5/11/2001 Date Approved Genaera Corporation 5110 Campus Drive Plymouth Meeting PA 19462 Generic Name: SS1(dsFv)-PE38 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/11/2002 Date Approved National Institutes of Health Cancer Therapy Evaluation Program/DCTD/NCI Suite 7111 Rockville MD 20852 Generic Name: SS1(dsFv)-PE38 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/11/2002 Date Approved National Institutes of Health Cancer Therapy Evaluation Program NCI/DCTD Rockville MD 20852 Generic Name: ST1-RTA immunotoxin (SR 44163) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/12/1987 Date Approved Sanofi Winthrop, Inc. 9 Great Valley Parkway Malvern PA 19355 Generic Name: ST1-RTA immunotoxin (SR 44163) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/12/1987 Date Approved Sanofi Winthrop, Inc. 9 Great Valley Parkway Malvern PA 19355 Generic Name: Staphylococcus aureus Immune Globulin (Human) Trade Name (if present): Altastaph Date Designated 1/29/2004 Date Approved Designation Approved: Sponsor Contact Information Nabi Biopharmaceuticals 12276 Wilkins Avenue Rockville MD 20852 Generic Name: Stem and progenitor cells derived from ex vivo expanded allogeneic umbilical cord blood Trade Name (if present): StemEx Date Designated 3/4/2005 Date Approved Designation Approved: Sponsor Contact Information Gamida Cell Ltd 5, Nahum Hafzadi St. Jerusalem 95484 ISRAEL Generic Name: Sterile talc Trade Name (if present): Steritalc Date Designated 12/8/1997 Date Approved Designation Approved: Sponsor Contact Information Novatech SA Avenue du Vent des Dames - Z.l. les Paluds 13685 Aubagne FRANCE Generic Name: Sterile talc Trade Name (if present): Steritalc Date Designated 12/8/1997 Date Approved Designation Approved: Sponsor Contact Information Novatech SA Avenue du Vent des Dames - Z.l. les Paluds 13685 Aubagne FRANCE Generic Name: Sterile talc powder Trade Name (if present): Sclerosol Intrapleural Aerosol Date Designated 9/18/1995 Date Approved 12/24/1997 Designation Approved: Prevention of recurrence of malignant pleural effusions in symptomatic patients. Sponsor Contact Information Bryan Corporation 4 Plympton Street Woburn MA 01801 Generic Name: SU101 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/12/1996 Date Approved Sugen, Inc. 230 East Grand Ave. South San Francisco CA 94080-4811 Generic Name: SU101 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/25/1995 Date Approved Sugen, Inc. 230 East Grand Ave. South San Francisco CA 94080-4811 Generic Name: Succimer Trade Name (if present): Chemet Date Designated 3/22/1991 Date Approved Designation Approved: Sponsor Contact Information Sanofi Winthrop, Inc. 90 Park Avenue New York NY 10016-1389 Generic Name: Succimer Trade Name (if present): Chemet Date Designated 11/5/1990 Date Approved Designation Approved: Sponsor Contact Information Sanofi Winthrop, Inc. 90 Park Avenue New York NY 10016-1389 Generic Name: Succimer Trade Name (if present): Chemet capsules Date Designated 5/9/1984 Date Approved 12/22/1988 Designation Approved: Sponsor Contact Information Bock Pharmacal Company P.O. Box 419056 Saint Louis MO 63141-9056 Generic Name: Sucralfate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/15/1993 Date Approved Fuisz Technologies, Ltd. 14555 Avion at Lakeside Chantilly VA 20151 Generic Name: Sucralfate suspension Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/12/1990 Date Approved Darby Pharmaceuticals, Inc. 100 Banks Avenue Rockville Centre NY 11570 Generic Name: Sucralfate suspension Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/4/1991 Date Approved Darby Pharmaceuticals, Inc. 100 Banks Avenue Rockville Centre NY 11570 Generic Name: Sulfadiazine Trade Name (if present): Designation Approved: Toxoplasmosis, as adjunctive with pyrimethamine Sponsor Contact Information Date Designated 3/14/1994 Date Approved 7/29/1994 Eon Labs Manufacturing, Inc. 227-15 North Conduit Avenue Laurelton NY 11413 Generic Name: Sulfapyridine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/10/1990 Date Approved Jacobus Pharmaceutical Company 37 Cleveland Lane P.O. Box 5290 Princeton NJ 08540 Generic Name: Superoxide dismutase (human) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/6/1985 Date Approved Pharmacia-Chiron Partnership 4560 Horton Street Emeryville CA 94608 Generic Name: Superoxide dismutase (recombinant human) Trade Name (if present): Oxsodrol Date Designated 5/17/1988 Date Approved Designation Approved: Sponsor Contact Information Bio-Technology General Corp. 70 Wood Avenue, South Iselin NJ 08830 Generic Name: Suramin Trade Name (if present): Metaret Date Designated 5/6/1997 Date Approved Designation Approved: Sponsor Contact Information Warner-Lambert Company Parke-Davis Pharmaceutical Research Division 2800 Plymouth Road Ann Arbor MI 48105-2430 Generic Name: Surface active extract of saline lavage of bovine lungs Trade Name (if present): Infasurf Date Designated 6/7/1985 Date Approved 1/1/9999 Designation Approved: Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants. Sponsor Contact Information ONY, Inc. 1576 Sweet Home Road Amherst NY 14228 Generic Name: Surfactant (human) (amniotic fluid derived) Trade Name (if present): Human Surf Date Designated 3/25/1987 Date Approved Designation Approved: Sponsor Contact Information Merritt, T. Allen M.D. 2516 Stockton Boulevard Sacramento CA 95817 Generic Name: Synsorb Pk Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/17/1995 Date Approved Synsorb Biotech Inc. 201, 1204 Kensington Road, N.W. Calgary, Alberta CANADA Generic Name: Synthetic Human Parathyroid Hormone 1-34 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/26/2001 Date Approved Rare Disease Therapeutics, Inc. 1101 Kermit Drive, Suite 608 Nashville TN 37217 Generic Name: Synthetic human secretin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/18/2006 Date Approved Repligen Corporation 41 Seyon Street Waltham MA 02453 Generic Name: Synthetic human secretin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/16/1999 Date Approved ChiRhoClin, Inc. 15500 Gallaudet Ave. Silver Spring MD 20905-4176 Generic Name: Synthetic human secretin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/7/2000 Date Approved ChiRhoClin, Inc. 15500 Gallaudet Ave. Silver Spring MD 20905-4176 Generic Name: Synthetic human secretin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/16/1999 Date Approved ChiRhoClin, Inc. 15500 Gallaudet Ave. Silver Spring MD 20905-4176 Generic Name: Synthetic human secretin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/16/1999 Date Approved ChiRhoClin, Inc. 1550 Gallaudet Ave. Silver Spring MD 20905-4176 Generic Name: Synthetic porcine secretin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/18/1999 Date Approved ChiRhoClin, Inc. 15500 Gallaudet Ave. Silver Spring MD 20905-4176 Generic Name: Synthetic porcine secretin Trade Name (if present): Date Designated 6/18/1999 Date Approved 11/1/2002 Designation Approved: For use in secretin stimulation testing for: Stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangio-pancreatography (ERCP) Sponsor Contact Information ChiRhoClin, Inc. 15500 Gallaudet Ave. Silver Spring MD 20905-4176 Generic Name: Synthetic porcine secretin Trade Name (if present): Designation Approved: Use in secretin stimulation testing for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction Sponsor Contact Information Date Designated 3/7/2000 Date Approved 4/4/2002 ChiRhoClin, Inc. 15500 Gallaudet Ave. Silver Spring MD 20905-4176 Generic Name: Synthetic porcine secretin Trade Name (if present): Designation Approved: Use in secretin stimulation testing for stimulation of gastrin secretion to aid in the diagnosis of gastrinoma Sponsor Contact Information Date Designated 6/18/1999 Date Approved 4/4/2002 ChiRhoClin, Inc. 15500 Gallaudet Ave. Silver Spring MD 20905-4176 Generic Name: T4 endonuclease V, liposome encapsulated Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/27/1989 Date Approved AGI Dermatics 205 Buffalo Avenue Freeport NY 11520 Generic Name: Tacrolimus Trade Name (if present): Prograf Date Designated 6/6/2005 Date Approved 3/29/2006 Designation Approved: Prophylaxis of organ rejection in patients receiving allogenic heart transplants. Sponsor Contact Information Astellas Pharma US, Inc. Three Parkway North Deerfield IL 60015-2548 Generic Name: Tacrolimus Trade Name (if present): Prograf Date Designated 4/6/1998 Date Approved Designation Approved: Sponsor Contact Information Fujisawa USA, Inc. 3 Parkway North Center Deerfield IL 60015 Generic Name: Tadalafil Trade Name (if present): Cialis Date Designated 12/18/2006 Date Approved Designation Approved: Sponsor Contact Information Eli Lilly and Company Lilly Corporate Center Indianapolis IN 46285 Generic Name: TAK-603 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/13/1998 Date Approved Tap Holdings Inc. 2355 Waukegan Road Deerfield IL 60015 Generic Name: Talactoferrin alfa Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/8/2007 Date Approved Agennix, Inc. 8 Greenway Plaza Houston TX 77046 Generic Name: talactoferrin alfa Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/29/2006 Date Approved Agennix, Inc. 8 Greenway Plaza Suite 910 Houston TX 77046 Generic Name: talactoferrin alfa Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/20/2003 Date Approved Agennix, Inc. Greenway Plaza Suite 910 Houston TX 77046 Generic Name: talactoferrin alfa Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/20/2003 Date Approved Agennix, Inc. 8 Greenway Plaza Suite 910 Houston TX 77046 Generic Name: talampanel Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/24/2008 Date Approved TEVA Neuroscience P. O. Box 1005 Horsham PA 19044-8005 Generic Name: Talotrexin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/8/2006 Date Approved Hana Biosciences, Inc. 7000 Shoreline Court Suite 370 South San Francisco CA 94080 Generic Name: Tamibarotene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/11/2007 Date Approved Innovive Pharmaceuticals 555 Madison Avenue New York NY 10022 Generic Name: Tanespimycin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/9/2004 Date Approved Kosan Biosciences, Inc 3832 Bay Center Place Hayward CA 94545 Generic Name: T-cell depleted stem cell enriched cellular product from peripheal b lood stem cells Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/1/2001 Date Approved Nexell Therapeutics Inc. 9 Parker Irvine CA 92618-1605 Generic Name: TD-K6a.513a.12 Trade Name (if present): ReveKer Date Designated 6/15/2006 Date Approved Designation Approved: Sponsor Contact Information TransDerm, Inc. 2161 Delaware Aenue Santa Cruz CA 95060 Generic Name: Technetium Tc 99m pterotetramide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/16/2000 Date Approved Endocyte, Inc. 1205 Kent Ave. West Lafayette IN 47906 Generic Name: Technetium Tc99m anti-melanoma murine monoclonal antibody Trade Name (if present): Oncotrac Melanoma Imaging Kit Date Designated 6/2/1987 Date Approved Designation Approved: Sponsor Contact Information NeoRx Corporation 410 West Harrison Seattle WA 98119-4007 Generic Name: Technetium Tc99m murine monoclonal antibody (IgG2a) to B cell Trade Name (if present): LymphoScan Date Designated 4/7/1992 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Technetium Tc99m murine monoclonal antibody to hCG Trade Name (if present): Immuraid, hCG-Tc-99m Date Designated 8/7/1989 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Technetium Tc99m murine monoclonal antibody to human AFP Trade Name (if present): AFP-Scan Date Designated 8/1/1989 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Technetium Tc99m murine monoclonal antibody to human alpha-fetoprotein Trade Name (if present): Immuraid, AFP-Scan Date Designated 8/1/1989 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Road Morris Plains NJ 07950 Generic Name: Technetium Tc99m rh-Annexin V Trade Name (if present): Apomate Date Designated 11/3/2000 Date Approved Designation Approved: Sponsor Contact Information Theseus Imaging Corporation 124 Mount Auburn Street Suite 200 North Cambridge MA 02138 Generic Name: Tegafur/gimeracil/oteracil Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/20/2006 Date Approved Taiho Pharma USA, Inc. 210 Carnegie Center Princeton NJ 08540 Generic Name: temocillin sodium Trade Name (if present): Negaban Date Designated 4/21/2004 Date Approved Designation Approved: Sponsor Contact Information Belpharma N.V. 67 Winston Churchill Avenue Brussels BELGIUM Generic Name: Temoporfin Trade Name (if present): Foscan Date Designated 10/28/1999 Date Approved Designation Approved: Sponsor Contact Information Biolitec Pharma Ireland Ltd. United Drug House Dublin IRELAND Generic Name: temozolomide Trade Name (if present): Temodar Date Designated 10/5/1998 Date Approved 3/15/2005 Designation Approved: Treatment of adult patients with newly diagnosed glioblastoma multiforme concomitatly with radiotherapy and then as maintenance treatment Sponsor Contact Information Schering-Plough Reasearch Institute 2000 Galloping Hill Rd. Kenilworth NJ 07033 Generic Name: Temozolomide Trade Name (if present): Temodal Date Designated 10/18/2004 Date Approved Designation Approved: Sponsor Contact Information Schering-Plough Research Institute 2000 Galloping Hill Road Kenilworth NJ 07033 Generic Name: Temozolomide Trade Name (if present): Temodal Date Designated 10/14/1998 Date Approved Designation Approved: Sponsor Contact Information Schering-Plough Research Institute 2000 Galloping Hill Rd. Kenilworth NJ 07033 Generic Name: Temozolomide Trade Name (if present): Temodar Date Designated 10/5/1998 Date Approved 8/11/1999 Designation Approved: Treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine. Sponsor Contact Information Schering-Plough Research Institute 2000 Galloping Hill Rd. Kenilworth NJ 07033 Generic Name: Temsirolimus Trade Name (if present): Torisel Date Designated 12/16/2004 Date Approved 5/30/2007 Designation Approved: Treatment of advanced renal cell carcinoma Sponsor Contact Information Wyeth Pharmaceuticals, Inc. P. O. Box 8299 Phildelphia PA 19101-8299 Generic Name: Teniposide Trade Name (if present): Vumon for injection Date Designated 11/1/1984 Date Approved 7/14/1992 Designation Approved: Induction therapy in patients with refractory childhood acute lymphoblastic leukemia when used in combination with other approved anticancer agents. Sponsor Contact Information Bristol-Myers Squibb Pharmaceutical Research Institute 5 Research Parkway P.O. Box 5100 Wallingford CT 06492 Generic Name: Teriparatide Trade Name (if present): Parathar Date Designated 1/9/1987 Date Approved 12/23/1987 Designation Approved: Sponsor Contact Information Rhone-Poulenc Rorer Pharmaceuticals, Inc. 500 Arcola Road Collegeville PA 19426 Generic Name: Teriparatide Trade Name (if present): Parathar Date Designated 10/28/1999 Date Approved Designation Approved: Sponsor Contact Information Henri Beaufour Institute USA, Inc. 27 Maple St. Milford MA 01757 Generic Name: Terlipressin Trade Name (if present): Glypressin Date Designated 3/6/1986 Date Approved Designation Approved: Sponsor Contact Information Ferring Laboratories, Inc. 400 Rella Boulevard, Suite 201 Suffern NY 10901 Generic Name: Terlipressin (INN) Trade Name (if present): Designation Approved: Fast Track granted by CDER. A rolling NDA submission is planned by the sponsor. Sponsor Contact Information Date Designated 10/29/2004 Date Approved Orphan Therapeutics, LLC 3 Werner Way Round Valley Executive Center Lebanon NJ 08833 Generic Name: Testosterone Trade Name (if present): Androgel Date Designated 2/5/1996 Date Approved Designation Approved: Sponsor Contact Information Unimed Pharmaceuticals, Inc. 901 Sawyer Rd. Marietta GA 30062 Generic Name: Testosterone Trade Name (if present): TheraDerm Testosterone Transdermal System Date Designated 9/22/1997 Date Approved Designation Approved: Sponsor Contact Information Watson Laboratories Research Park 417 Wakara Way Salt Lake City UT 84108 Generic Name: Testosterone propionate ointment 2% Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/31/1991 Date Approved Star Pharmaceuticals, Inc. 1990 N.W. 44th Street Pompano Beach FL 33064 Generic Name: Testosterone sublingual Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/16/1991 Date Approved Bio-Technology General Corp. 70 Wood Avenue South Iselin NJ 08830 Generic Name: Tetrabenazine Trade Name (if present): Xenazine Date Designated 12/11/1997 Date Approved Designation Approved: Sponsor Contact Information Prestwick Pharmaceuticals, Inc 1825 K Street NW Suite 1475 Washington DC 20006 Generic Name: Tetrabenazine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/12/1998 Date Approved Prestwick Pharmaceuticals, Inc. 1825 K Street, NW Suite 1475 Washington DC 20006 Generic Name: Tetraiodothyroacetic acid Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/1/2000 Date Approved Danforth, Jr., MD, Elliot University of Vermont 84 Beartown Rd. Underhill VT 05489 Generic Name: Tezacitabine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/27/2003 Date Approved Sanofi-Aventis Pharma 9 Great valley Parkway Malvern PA 19355-1304 Generic Name: TGF(beta)2-specific phosphorothioate antisense oligodeoxynucleotide Trade Name (if present): Oncomun Date Designated 6/5/2002 Date Approved Designation Approved: Sponsor Contact Information Antisense Pharma GmbH Josef-Engert-Str. 9 93053 Regensberg GERMANY Generic Name: TGp1PTH1-34 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/2007 Date Approved Kuros Biosurgery AG Technoiparkstrasse 1 Zurich SWITZERLAND Generic Name: Thalidomide Trade Name (if present): Thalomid Date Designated 9/27/2004 Date Approved Designation Approved: Sponsor Contact Information Celgene Corporation 86 Morris Avenue Summit NJ 07901 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/15/1995 Date Approved Andrulis Research Corporation 11800 Baltimore Avenue, Suite 113 Beltsville MD 20705 Generic Name: Thalidomide Trade Name (if present): Synovir Date Designated 3/11/1996 Date Approved Designation Approved: Sponsor Contact Information Celgene Corporation P.O. Box 4914 7 Powder Horn Drive Warren NJ 07059 Generic Name: Thalidomide Trade Name (if present): Thalomid Date Designated 4/6/1999 Date Approved Designation Approved: Sponsor Contact Information Celgene Corporation 7 Powder Horn Dr. Warren NJ 07059 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/19/1988 Date Approved Pediatric Pharmaceuticals, Inc. 718 Bradford Avenue Westfield NJ 07090 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/19/1988 Date Approved Pediatric Pharmaceuticals, Inc. 718 Bradford Avenue Westfield NJ 07090 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/15/1988 Date Approved Pediatric Pharmaceuticals, Inc. 718 Bradford Avenue Westfield NJ 07090 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/12/1993 Date Approved Celgene Corporation P.O. Box 4914 7 Powder Horn Drive Warren NJ 07059 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/5/1990 Date Approved Andrulis Research Corporation 11800 Baltimore Avenue, Suite 113 Beltsville MD 20705 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/5/1990 Date Approved Andrulis Research Corporation 11800 Baltimore Avenue, Suite 113 Beltsville MD 20705 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/27/1998 Date Approved Celgene Corporation 7 Powder Horn Dr. Warren NJ 07059 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/1/1995 Date Approved Celgene Corporation P.O. Box 4914 7 Powder Horn Srive Warren NJ 07059 Generic Name: Thalidomide Trade Name (if present): Thalomid Date Designated 7/26/1995 Date Approved 7/16/1998 Designation Approved: Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences. Sponsor Contact Information Celgene Corporation 86 Morris Avenue Summit NJ 07901 Generic Name: Thalidomide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/29/1998 Date Approved Celgene Corporation 7 Powder Horn Dr. Warren NJ 07059 Generic Name: Thalidomide Trade Name (if present): Thalomid Date Designated 10/14/1998 Date Approved 5/25/2006 Designation Approved: Treatment of patients with newly diagnosed multiple myeloma Sponsor Contact Information Celgene Corporation 7 Powder Horn Dr. Warren NJ 07059 Generic Name: Thiotepa Trade Name (if present): Tepadina Date Designated 4/2/2007 Date Approved Designation Approved: Sponsor Contact Information Adienne S.r.l. 24128 Bergamo, 64/B Broseta Street Bergamo ITALY Generic Name: Thymalfasin Trade Name (if present): Zadaxin Date Designated 3/13/2006 Date Approved Designation Approved: Sponsor Contact Information SciClone Pharmaceuticals, Inc. 901 Mariner's Island Blvd San Mateo CA 94404 Generic Name: Thymalfasin Trade Name (if present): Zadaxin Date Designated 5/3/1991 Date Approved Designation Approved: Sponsor Contact Information SciClone Pharmaceuticals, Inc. 950 Tower Lane Suite 900 Foster City CA 94404-2125 Generic Name: Thymalfasin Trade Name (if present): Zadaxin Date Designated 1/8/1998 Date Approved Designation Approved: Sponsor Contact Information SciClone Pharmaceuticals, Inc. 901 Mariner's Island Blvd. San Mateo CA 94404-1593 Generic Name: Thymalfasin Trade Name (if present): Zadaxin Date Designated 3/6/2000 Date Approved Designation Approved: Sponsor Contact Information SciClone Pharmaceuticals, Inc. 901 Mariner's Blvd., Suite 205 San Mateo CA 94404-1593 Generic Name: Thymosin beta 4 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/28/2004 Date Approved RegeneRx Biopharmaceuticals, Inc. 3 Bethesda Metro Center Suite 700 Bethesda MD 20814 Generic Name: Thymoxamine HCl Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/16/1987 Date Approved Iolab Pharmaceuticals 500 Iolab Drive Claremont CA 91711 Generic Name: Thyrotropin alfa Trade Name (if present): Thyrogen Date Designated 8/3/2001 Date Approved 12/14/2007 Designation Approved: For use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone thyroidectomy for welldifferentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer Sponsor Contact Information Genzyme Corporation One Kendall Square Cambridge MA 02139-1562 Generic Name: Thyrotropin alpha Trade Name (if present): Thyrogen Date Designated 2/24/1992 Date Approved 11/30/1998 Designation Approved: As an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer. Sponsor Contact Information Genzyme Corporation One Kendall Square Cambridge MA 02139 Generic Name: Tiapride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/21/1998 Date Approved Sanofi-Synthelabo, Inc. 9 Great Valley Parkway PO Box 3026 Malvern PA 19355 Generic Name: Tiazofurin (2-Beta-D-ribofuranosyl-4thiazolecarboxamide) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/27/2000 Date Approved Valeant Research & Development 3300 Hyland Avenue Costa Mesa CA 92626 Generic Name: Tilarginine acetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/11/2005 Date Approved Arginox Pharmceuticals, Inc. 120 Constitution Drive Menlo Park CA 94025 Generic Name: tin ethyl etiopurpurin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/4/2003 Date Approved Miravant Medical Technologies 336 Bollay Drive Goleta CA 93117 Generic Name: tinidazole Trade Name (if present): Tindamax Date Designated 4/18/2002 Date Approved 5/17/2004 Designation Approved: Treatment of giardiasis caused by G. duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age Sponsor Contact Information Presutti Laboratories, Inc. 1607 N. Douglas Ave. Arlington Heights IL 60004 Generic Name: Tinidazole Trade Name (if present): Tindamax Date Designated 8/20/2003 Date Approved 5/17/2004 Designation Approved: Treatment of intestinal amebiasis and amebic liver abcess caused by E. histolytica in both adults and pediatric patients older than three years of age. It is not indicated for the treatment of asymptomatic cyst passage. Sponsor Contact Information Presutti Laboratories, Inc. 1607 N. Douglas Avenue Arlington Heights IL 60004 Generic Name: Tiopronin Trade Name (if present): Thiola Date Designated 1/17/1986 Date Approved 8/11/1988 Designation Approved: Sponsor Contact Information Pak, Charles Y.C. M.D. The University of Texas Health Scienc Center at Da 5323 Harry Hines Boulevard Dallas TX 75235 Generic Name: Tiotropium bromide Trade Name (if present): Spiriva Date Designated 1/8/2008 Date Approved Designation Approved: Sponsor Contact Information Boehringer Ingelheim Pharmaceuticals, Inc. P. O. Box 368 900 Ridgebury Road Ridgefield CT 06877 Generic Name: Tipifarnib Trade Name (if present): Zarnestra Date Designated 7/6/2004 Date Approved Designation Approved: Sponsor Contact Information Johnson & Johnson Pharmaceutical Research & Dev. 920 U.S. Highway 202 Raritan NJ 08869 Generic Name: tirapazamine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 10/23/2002 Date Approved Sanofi-Aventis US, Inc. 11 Great Valley Parkway P. O. Box 3026 Malvern PA 19355 Generic Name: Tiratricol Trade Name (if present): Triacana Date Designated 8/13/1991 Date Approved Designation Approved: Sponsor Contact Information Laphal Laboratoires 48 Bis, Rue des Belles-Feuilles 75116 Paris FRANCE Generic Name: Tissue repair cells obtained from autologous bone marrow expanded ex vivo with a cell production system Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/13/2006 Date Approved Aastrom Biosciences, Inc. Domino's Farms 24 Frank Lloyd Wright Drive Ann Arbor MI 48105 Generic Name: Tissue repair cells obtained from autologous bone marrow expanded ex vivo with a cell production system Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/25/2007 Date Approved Aastrom Biosciences, Inc. Domino's Farms, Lobby L Ann Arbor MI 48105 Generic Name: Titanium dioxide and bisoctrizole Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/25/2005 Date Approved Orfagen Parc Technologique Du Canal-4 31521 Ramonville Saint Agne FRANCE Generic Name: Tizanidine HCl Trade Name (if present): Zanaflex Date Designated 1/31/1994 Date Approved Designation Approved: For the acute and intermittent management of increased muscle tone associated with spasticity. Sponsor Contact Information Athena Neurosciences, Inc. 800 Gateway Boulevard South San Francisco CA 94080 Generic Name: Tobramycin Trade Name (if present): Tobi Date Designated 6/18/1999 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaceuticals Corp. Drug Regulatory Affairs One Health Plaza East Hanover NJ 07936-1080 Generic Name: Tobramycin for inhalation Trade Name (if present): TOBI Date Designated 10/13/1994 Date Approved 12/22/1997 Designation Approved: Management of cystic fibrosis patients with P.aeruginosa. Sponsor Contact Information Novartis Pharmaceuticals Corp Drug Regulatory Affairs One Health Plaza East Hanover NJ 07936-1080 Generic Name: Tocophersolan oral solution (vitamin Etpgs) Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/15/1988 Date Approved Sterling Winthrop 9 Great Valley Parkway Malvern PA 19355 Generic Name: Topiramate Trade Name (if present): Topamax Date Designated 11/25/1992 Date Approved 8/28/2001 Designation Approved: As adjunctive therapy in patients two years and older with siezures associated with Lennox-Gastaut syndrome. Sponsor Contact Information Johnson & Johnson Pharmaceutical R & D, LLC Route 202, P.O. Box 300 Raritan NJ 08869-0602 Generic Name: toralizumab Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/14/2002 Date Approved Biogen IDEC Inc. 3030 Callan Road San Diego CA 92121 Generic Name: Toremifene Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/17/1993 Date Approved Orion Corporation P.O. Box 65 02101 Espoo FINLAND Generic Name: Toremifene Trade Name (if present): Fareston Date Designated 9/19/1991 Date Approved 5/29/1997 Designation Approved: Treatment of metastatic breast cancer in postmenopausal women with estrogen positive or receptor unknown tumors. Sponsor Contact Information Orion Corporation P.O. Box 65 02101 ESPOO FINLAND Generic Name: Tositumomab and iodine I 131 tositumomab Trade Name (if present): Bexxar Date Designated 5/16/1994 Date Approved 6/27/2003 Designation Approved: Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy Sponsor Contact Information GlaxoSmithKline 2301 Renaissance Blv. P.O. Box 61540 King of Prussia PA 19406-2772 Generic Name: trabectedin Trade Name (if present): Yondelis Date Designated 9/30/2004 Date Approved Designation Approved: Sponsor Contact Information Johnson & Johnson Pharmaceutical Research & Dev. 920 US Highway 202 Raritan NJ 08869 Generic Name: trabectedin Trade Name (if present): Yondelis Date Designated 3/29/2005 Date Approved Designation Approved: Sponsor Contact Information Johnson & Johnson Pharmaceutical Research & Dev. 920 U S Highway 202 Raritan NJ 08869 Generic Name: Tramadol hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/26/2005 Date Approved TheraQuest Biosciences, LLC 146 Medinah Drive Blue Bell PA 19422-3212 Generic Name: Tramadol hydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/28/2005 Date Approved TheraQuest Biosciences, LLC 146 Medinah Drive Blue Bell PA 19422-3212 Generic Name: Tranexamic acid Trade Name (if present): Cyklokapron Date Designated 10/29/1985 Date Approved 12/30/1986 Designation Approved: Sponsor Contact Information Pharmacia Inc. P.O. Box 16529 Columbus OH 43216 Generic Name: Tranexamic acid Trade Name (if present): Cyklokapron Date Designated 7/23/1987 Date Approved Designation Approved: Sponsor Contact Information Pharmacia Inc. P.O. Box 16529 Columbus OH 43216 Generic Name: Tranexamic acid Trade Name (if present): Cyklokapron Date Designated 9/9/1985 Date Approved Designation Approved: Sponsor Contact Information Pharmacia Inc. P.O. Box 16529 Columbus OH 43216 Generic Name: Tranilast Trade Name (if present): Rizaben Date Designated 12/2/2003 Date Approved Designation Approved: Sponsor Contact Information Angiogen Pharmaceuticals, Pty. Ltd. Level 31, ABN AMRO Tower 88 Phillip Street Sydney, N.S.W. 2000 AUSTRALIA Generic Name: Transforming growth factor-beta 2 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/18/1992 Date Approved Celtrix Pharmaceuticals, Inc. 3055 Patrick Henry Drive Santa Clara CA 95054 Generic Name: Transgenic human alpha 1 antitrypsin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/19/1999 Date Approved PPL Therapeutics (Scotland) Limited Roslin, Edinburgh EH259PP Scotland UNITED KINGDOM Generic Name: Trastuzumab Trade Name (if present): Herceptin Date Designated 12/14/1999 Date Approved Designation Approved: Sponsor Contact Information Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990 Generic Name: Treosulfan Trade Name (if present): Ovastat Date Designated 5/16/1994 Date Approved Designation Approved: Sponsor Contact Information Medac GmbH Fehlandtstrasse 3 D-20354 Hamburg GERMANY Generic Name: treprostinil Trade Name (if present): Remodulin Date Designated 6/4/1997 Date Approved 5/21/2002 Designation Approved: Treatment of pulmonary arterial hypertension. Sponsor Contact Information United Therapeutics Corp. 68 T.W. Alexander Dr. P.O. Box 14186 Research Triangle Park NC 27709 Generic Name: Tretinoin Trade Name (if present): Vesanoid Date Designated 10/24/1990 Date Approved 11/22/1995 Designation Approved: Induction of remission in patients with acute promyelocytic leukemia who are refractory to or unable to tolerate anthracycline based cytotoxic chemotherapeutic regimens. Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Tretinoin Trade Name (if present): ATRA-IV Date Designated 1/14/1993 Date Approved Designation Approved: Sponsor Contact Information Antigenics, Inc. 3 Forbes Road Lexington MA 02421 Generic Name: Tretinoin Trade Name (if present): ATRA-IV Date Designated 4/11/2003 Date Approved Designation Approved: Sponsor Contact Information Antigenics, Inc. 3 Forbes Road Lexington MA 02421 Generic Name: Tretinoin Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 4/15/1985 Date Approved Hannan Ophthalmic Marketing Services, Inc 34 Sherrill Rd. Marshfield MA 02050 Generic Name: tri-antennary glycotripeptide derivative of 5-fluorodeoxyuridine monophosphate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/23/2001 Date Approved Cell Works Inc. 6200 Seaforth Street Baltimore MD 21224-6506 Generic Name: triciribine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/2008 Date Approved VioQuest Pharmaceuticals, Inc. 180 Mt. Airy Road Basking Ridge NJ 07920 Generic Name: Trientine HCl Trade Name (if present): Syprine Date Designated 12/24/1984 Date Approved 11/8/1985 Designation Approved: Sponsor Contact Information Merck Sharp & Dohme Research Division Of Merck And Company West Point PA 19486 Generic Name: Triheptanoin Trade Name (if present): Triheptanoin-SASOL Special Oil Date Designated 2/1/2008 Date Approved Designation Approved: Sponsor Contact Information Baylor Research Institute 3330 Live Oak Blvd Dallas TX 75204 Generic Name: Triheptanoin Trade Name (if present): Triheptanoim-SASOl Special Oil Date Designated 5/26/2006 Date Approved Designation Approved: Sponsor Contact Information Baylor Research Institute Institute of Metabolic Disease 3812 Elm Street Dallas TX 75226 Generic Name: Trimetrexate Trade Name (if present): Neutrexin Date Designated 8/10/2000 Date Approved Designation Approved: Sponsor Contact Information Medimmune Oncology, Inc. One MedImmune Way Gaithersburg MD 20878 Generic Name: Trimetrexate glucuronate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/13/1988 Date Approved Medimmune Oncology, Inc. One MedImmune Way Gaithersburg MD 20878 Generic Name: Trimetrexate glucuronate Trade Name (if present): Neutrexin Date Designated 5/15/1986 Date Approved 12/17/1993 Designation Approved: Concurrent leucovorin administration as an alternative therapy for the treatment of moderate to severe PCP in immunocompromised patients who are intolerant of, or are refractory to, trimethoprim sulfamethoxazole. Sponsor Contact Information Medimmune Oncology, Inc. One Tower Bridge 100 Front Street, Suite 400 West Conshohocken PA 19428 Generic Name: Trimetrexate glucuronate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/25/1985 Date Approved Medimmune Oncology, Inc. One MedImmune Way Gaithersburg MD 20878 Generic Name: Trimetrexate glucuronate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/25/1985 Date Approved Medimmune Oncology, Inc. One MedImmune Way Gaithersburg MD 20878 Generic Name: Trimetrexate glucuronate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 7/25/1985 Date Approved Medimmune Oncology, Inc. One MedImmune Way Gaithersburg MD 20878 Generic Name: Triptorelin pamoate Trade Name (if present): Decapeptyl Injection Date Designated 8/10/1990 Date Approved Designation Approved: Sponsor Contact Information Debio R.A. Inc. 7929 Westpark Drive, Suite 400 Mclean VA 22102 Generic Name: Trisaccharides A and B Trade Name (if present): Biosynject Date Designated 4/12/1987 Date Approved Designation Approved: Sponsor Contact Information Chembiomed, Ltd. P.O. Box 8050, Station F Edmonton, Alberta CANADA Generic Name: Trisaccharides A and B Trade Name (if present): Biosynject Date Designated 4/15/1988 Date Approved Designation Approved: Sponsor Contact Information Chembiomed, Ltd. P.O. Box 8050 Edmonton, Alberta CANADA Generic Name: Trisaccharides A and B Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 8/3/1987 Date Approved Chembiomed, Ltd. P.O. Box 8050 Edmonton, Alberta CANADA Generic Name: Trisaccharides A and B Trade Name (if present): Biosynject Date Designated 4/20/1987 Date Approved Designation Approved: Sponsor Contact Information Chembiomed, Ltd. P.O. Box 8050 Edmonton, Alberta CANADA Generic Name: Trisodium citrate concentration Trade Name (if present): Hemocitrate Date Designated 6/15/1995 Date Approved Designation Approved: Sponsor Contact Information Hemotec Medical Products, Inc. Box 19255 Johnston RI 02919 Generic Name: Trisodium zinc Diethylenetriaminepentaacetate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/27/2004 Date Approved CustomCare Pharmacy 5710 Hoover Blvd Tampa FL 33634 Generic Name: Troxacitabine Trade Name (if present): Troxatyl Date Designated 4/4/2005 Date Approved Designation Approved: Sponsor Contact Information Structural GenomiX, Inc. (SGX) 10505 Roselle Street San Diego CA 92121 Generic Name: Trypan blue Trade Name (if present): MembraneBlue Date Designated 8/2/2006 Date Approved Designation Approved: Sponsor Contact Information Dutch Ophthalmic Research Center Int'l BV Scheijdelveweg 2 P.O. Box 43 3214ZG Zuidland NETHERLANDS Generic Name: Tumor necrosis factor-binding protein 1 Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/6/1993 Date Approved Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Tumor necrosis factor-binding protein II Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 1/6/1993 Date Approved Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Tyloxapol Trade Name (if present): Supervent Date Designated 3/8/1995 Date Approved Designation Approved: Sponsor Contact Information Kennedy & Hoidal, M.D.'s University of Utah Health Sciences Center 50 North Medical Drive, Room 4R240 Salt Lake City UT 84132-0001 Generic Name: Type 1 native bovine skin collagen Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 2/1/2008 Date Approved arGentis Pharmaceuticals, LLC 20 South Dudley Street Memphis TN 38139 Generic Name: tyrosine kinase inhibitor Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 9/14/2005 Date Approved AB Science 3, avenue GeorgeV 75008 Paris FRANCE Generic Name: Ubiquinol Trade Name (if present): Ubi-Q-Nol, Li-Q-Nol Date Designated 4/12/2004 Date Approved Designation Approved: Sponsor Contact Information Gel-Tec, Division of Tishcon Corp 30 New York Avenue P. O. Box 331 Westbury NY 11590 Generic Name: Ubiquinol, coenzyme Q10, ubiquinone Trade Name (if present): UBI-Q-NOL Date Designated 4/12/2004 Date Approved Designation Approved: Sponsor Contact Information Gel-Tec, Division of TISHCON Corporation 30 New York Avenue P.O. Box 331 Westbury NY 11590 Generic Name: Ubiquinone Trade Name (if present): Ubi-Q-Gel Date Designated 12/14/1999 Date Approved Designation Approved: Sponsor Contact Information Gel-Tec, Division of Tishcon Corp. 30 New York Ave. PO Box 331 Westbury NY 11590 Generic Name: Unconjugated Chimeric (human-murine) G250 IgG monoclonal antibody Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/22/2001 Date Approved Wilex Biotechnology GmbH Grillparzerstrasse 10B 81675 Munich GERMANY Generic Name: Urea for intravitreal injection Trade Name (if present): Neurosolve Date Designated 12/14/2005 Date Approved Designation Approved: Sponsor Contact Information Vitreo Retinal Techologies, Inc 2 Venture Plaza Irvine CA 92618 Generic Name: Uridine 5'-triphosphate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/26/1996 Date Approved Inspire Pharmaceuticals, Inc. 4222 Emperor Boulevard, Suite 470 Durham NC 27703 Generic Name: Uridine 5'-triphosphate Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/4/1995 Date Approved Inspire Pharmaceuticals, Inc. 4222 Emperor Boulevard, Suite 470 Durham NC 27703 Generic Name: Urofollitropin Trade Name (if present): Metrodin Date Designated 11/25/1987 Date Approved 9/18/1986 Designation Approved: Sponsor Contact Information Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061 Generic Name: Urofollitropin Trade Name (if present): Fertinex Date Designated 12/5/1997 Date Approved Designation Approved: Sponsor Contact Information Serono Laboratories, Inc. One Technology Place Rockland MA 02370 Generic Name: Urogastrone Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/1/1984 Date Approved Chiron Vision 500 Iolab Drive Claremont CA 91711 Generic Name: ursodiol Trade Name (if present): Ursofalk Suspension Date Designated 10/23/2007 Date Approved Designation Approved: Sponsor Contact Information Asklepion Pharmaceuticals, LLC 5200 Maryland Way Brentwood TN 37027 Generic Name: Ursodiol Trade Name (if present): Actigall Date Designated 2/19/1991 Date Approved Designation Approved: Sponsor Contact Information Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover NJ 07936-1080 Generic Name: Ursodiol Trade Name (if present): URSO Date Designated 6/20/1991 Date Approved 12/10/1997 Designation Approved: Sponsor Contact Information Axcan Pharma Inc. 597 Laurier Blvd Mount St. Hilaire Quebec H7L 4S3 Generic Name: Vaccinia Immune Globulin (Human) Intravenous Trade Name (if present): Designation Approved: treatment and/or modification of the following conditions, which are complications resulting from smallpox vaccination: Eczema vaccinatum Progressive vaccinia Severe generalized vaccinia Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicellazoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where CNJ-016 Date Designated 6/18/2004 Date Approved 1/1/9999 Sponsor Contact Information Cangene Corporation 104 Chancellor Matheson Road Winnipeg, ManitobaR3T 5Y3 CANADA Generic Name: Vaccinia Immune Globulin (Human) Intravenous Trade Name (if present): Designation Approved: Treatment and modification of aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard; eczema vaccinatum; progressive vaccinia; severe generalized vaccinia, and vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity Sponsor Contact Information Date Designated 6/18/2004 Date Approved 2/18/2005 DynPort Vaccine Company LLC 64 Thomas Johnson Drive Frederick MD 21702 Generic Name: Valine, isoleucine and leucine Trade Name (if present): VIL Date Designated 1/5/1996 Date Approved Designation Approved: Sponsor Contact Information Leas Research Products 78 Fallon Drive North Haven CT 06473 Generic Name: valine-valine-ganciclovir Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 5/21/2007 Date Approved Verenta Pharmaceuticals, Inc. 10901 Granada Lane Suite 101 Leawood KS 66211 Generic Name: Valproic acid, sodium Trade Name (if present): PEAC Date Designated 6/24/2005 Date Approved Designation Approved: Sponsor Contact Information Topo Target Germany AG Paul-Ehrlich Str. 42-44 D-60596 Frankfurt am Main GERMANY Generic Name: Valrubicin Trade Name (if present): Valstar Date Designated 5/23/1994 Date Approved 9/25/1998 Designation Approved: For intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. Sponsor Contact Information Anthra Pharmaceuticals, Inc. 103 Carnegie Center, Suite 102 Princeton NJ 08540 Generic Name: Vandetanib Trade Name (if present): Zactima Date Designated 10/21/2005 Date Approved Designation Approved: Sponsor Contact Information AstraZeneca Pharmaceutical LP 1800 Concord Pike Wilmington DE 19830-8355 Generic Name: Vapreotide Trade Name (if present): Sanvar Date Designated 4/6/2004 Date Approved Designation Approved: Sponsor Contact Information H3 Pharma, Inc. 666 Sherbrooke Street West Montreal, Quebec, CANADA Suite 1400 Generic Name: vapreotide Trade Name (if present): Sanvar Date Designated 1/10/2000 Date Approved Designation Approved: Sponsor Contact Information Debiovision, Inc. 666 Sherbrooke Street West Suite 1400 Montreal, Quebec H3A 1E7 CANADA Generic Name: vapreotide Trade Name (if present): Octastatin Date Designated 1/10/2000 Date Approved Designation Approved: Sponsor Contact Information Debiopharm S.A. 17 rue des Terreaux CH-1000 Lausanne 9 SWITZERLAND Generic Name: vapreotide Trade Name (if present): Octastatin Date Designated 3/6/2000 Date Approved Designation Approved: Sponsor Contact Information Debiopharm S.A. 17 rue des Terreaux CH-1000 Lausanne 9 SWITZERLAND Generic Name: vapreotide Trade Name (if present): Sanvar Date Designated 11/4/2003 Date Approved Designation Approved: Sponsor Contact Information H3 Pharma, Inc. 666 Sherbrooke Street West, Suite 1400 Montreal, Quebec Generic Name: varespladib sodium Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 11/19/2007 Date Approved Anthera Pharmaceuticals, Inc. 1900 S. Norfolk St. Suite 260 San Mateo CA 94403 Generic Name: Varicella Zoster Immune Globulin (Human) Trade Name (if present): VariZIG Date Designated 11/7/2006 Date Approved Designation Approved: Sponsor Contact Information Cangene Corporation 155 Innovation Drive R3T 5Y3 CANADA Generic Name: Vasoactive intestinal peptide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/9/2001 Date Approved mondoBIOTECH Europark Austrasse 79 Generic Name: Vasoactive intestinal polypeptide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/23/1993 Date Approved Research Triangle Pharmaceuticals 200 Westpark Corporate Center 4364 South Alston Avenue Durham NC 27713-2280 Generic Name: Vibriolysin Trade Name (if present): Vibrilase Date Designated 6/16/2006 Date Approved Designation Approved: Sponsor Contact Information BioMarin Pharmaceutical Inc. 105 Digital Drive Novato CA 94949 Generic Name: vigabatrin Trade Name (if present): Sabril Date Designated 6/12/2000 Date Approved Designation Approved: Sponsor Contact Information Ovation Pharmaceuticals, Inc. Four Parkway North Deerfield IL 60015 Generic Name: Viloxazine HCl Trade Name (if present): Catatrol Date Designated 6/11/1984 Date Approved Designation Approved: Sponsor Contact Information Stuart Pharmaceuticals Division of ICI Americas Wilmington DE 19897 Generic Name: Viloxazine HCl Trade Name (if present): Catatrol Date Designated 6/11/1984 Date Approved Designation Approved: Sponsor Contact Information Stuart Pharmaceuticals Division of ICI Americas Wilmington DE 19897 Generic Name: vincristine sulfate liposome injection Trade Name (if present): Marqibo Date Designated 1/8/2007 Date Approved Designation Approved: Sponsor Contact Information Hana Biosciences, Inc. 7000 Shoreline Court South San Francisco CA 94080 Generic Name: Virulizin Trade Name (if present): Virulizin Date Designated 2/1/2001 Date Approved Designation Approved: Sponsor Contact Information Lorus Therapeutics Inc. 7100 Woodbine Avenue, Suite 215 Markham, ON L3R 5J2 CANADA Generic Name: viscous budesonide Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/20/2006 Date Approved University of California San Diego Medical Center Hillcrest San Diego CA 92103-8450 Generic Name: vorinostat Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 6/12/2003 Date Approved Merck Research Laboratories Merck & Co., Inc. P. O. Box 2000, RY 32-605 Rahway NJ 07065-0900 Generic Name: vorinostat Trade Name (if present): Zolinza Date Designated 3/16/2004 Date Approved 10/6/2006 Designation Approved: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistant or recurrent disease on or following two systemic therapies. Sponsor Contact Information Merck & Co., Inc. P. O. Box 2000, RY 32-605 Rahway NJ 07065-0900 Generic Name: vorinostat Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 3/17/2004 Date Approved Merck & Co., Inc. P. O. Box 2000, RY 32-605 Rahway NJ 07065-0900 Generic Name: Xenogeneic hepatocytes Trade Name (if present): HepatAssist Liver Assist System Date Designated 11/27/1998 Date Approved Designation Approved: Sponsor Contact Information Circe Biomedical, Inc. 99 Hayden Ave. Lexington MA 02421-7995 Generic Name: Yttrium (90Y) antiferritin polyclonal antibodies Trade Name (if present): Ferritarg P Date Designated 9/18/2006 Date Approved Designation Approved: Sponsor Contact Information MAT Biopharma 4 rue Pierre Fontaine FRANCE Generic Name: Yttrium-90 radiolabeled humanized monoclonal anti-carcinoembroyonic antigen IgG antibody Trade Name (if present): Cea-Cide Date Designated 8/3/1999 Date Approved Designation Approved: Sponsor Contact Information Immunomedics, Inc. 300 American Rd. Morris Plains NJ 07950 Generic Name: Zalcitabine Trade Name (if present): Hivid Date Designated 6/28/1988 Date Approved 6/19/1992 Designation Approved: Combination therapy with zidovudine is indicated for the treatment of adult patients with advanced HIV infection (CD4 count < 300) who have demonstrated malignant clinical or immunologic deterioration. Sponsor Contact Information Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley NJ 07110 Generic Name: Zalcitabine Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/9/1986 Date Approved National Cancer Institute, DCT NIH, Executive Plaza North, Room 7-18 Bethesda MD 20892 Generic Name: Zidovudine Trade Name (if present): Retrovir Date Designated 7/17/1985 Date Approved 3/19/1987 Designation Approved: Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Zidovudine Trade Name (if present): Retrovir Date Designated 7/17/1985 Date Approved 3/19/1987 Designation Approved: Sponsor Contact Information Glaxo Wellcome Inc. 5 Moore Drive Research Triangle Park NC 27709 Generic Name: Zinc acetate Trade Name (if present): Galzin Date Designated 11/6/1985 Date Approved 1/28/1997 Designation Approved: For maintenance treatment of patients with Wilson's disease who have been initially treated with a chelating agent. Sponsor Contact Information Lemmon Company 1510 Delp Drive Kulpsville PA 19443 Generic Name: Zoledronate Trade Name (if present): Zometa, Zabel Date Designated 8/18/2000 Date Approved 8/20/2001 Designation Approved: Treatment of hypercalcemia of malignancy. Sponsor Contact Information Novartis Pharmaceuticals Corp. 59 Route 10 East Hanover NJ 07936-1080 Generic Name: Zosuquidar trihydrochloride Trade Name (if present): Designation Approved: Sponsor Contact Information Date Designated 12/15/2005 Date Approved Kanisa Pharmaceuticals, Inc. 12264 El Camino Real San Diego CA 02130