List of Orphan Products Receiving Designation during the Year 2008
Total Number of Active Designations
Generic Name:
47
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: (+/- 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: (+/-)-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: (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: 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: 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: 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-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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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: 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: 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