Cumulative List of Designated Approved Orphan Products
Total Number of Active Designations 325
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
Effective: 4/14/2008
Sponsor Contact Information
Cumberland Pharmaceuticals, Inc. 209 10th Street South Suite 332 Nashville TN 37203
Generic Name: Adalimumab Trade Name (if present): Humira Date Designated 3/21/2005 Date Approved 2/21/2008
Designation Approved:
Treatment of Jevenile Idiopathic Arthritis
Sponsor Contact Information
Abbott Laboratories 200 Abbott Park Road Abbott Park IL 60064-6157
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: 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 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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): 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: 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: 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: 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: 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-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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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 11/7/1990 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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 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: 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 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: 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: 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: 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-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα 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: 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: 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: 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 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: 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 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-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 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-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 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: 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: 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: 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: 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 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: 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: 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 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: 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: 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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: 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: 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 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 8/21/1996 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 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: 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: 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: 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: 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: 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: 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: 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_®(imatinib)
Sponsor Contact Information
Novartis Pharmaceutical Corporation One Health Plaza East Hanover NJ 07936-1080
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 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): 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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 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: 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 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: 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: 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: 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: 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: 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: 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 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: 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: 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): 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: 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: 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 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: 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 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: 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: 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: 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.
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Biomarin Pharmaceutical Inc. 371 Bel Marin Blvd. Novato CA 94949
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.
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Immunex Corporation 51 University Street Seattle WA 98101
Generic Name: Sargramostim Trade Name (if present): Leukine Date Designated 5/3/1990 Date Approved 3/5/1991
Designation Approved:
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Immunex Corporation 51 University Street Seattle WA 98101
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.
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Cytogen Corporation 600 College Road East Princeton NJ 08540
Generic Name: Selegiline HCl Trade Name (if present): Eldepryl Date Designated 11/7/1984 Date Approved 6/5/1989
Designation Approved:
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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:
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Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061
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.
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Medicis Pharmaceutical Corp. 8125 N. Hayden Road Scottsdale AZ 85258
Generic Name: Somatrem for injection Trade Name (if present): Protropin Date Designated 12/9/1985 Date Approved 10/17/1985
Designation Approved:
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Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080
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
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Novo Nordisk Inc. 100 College Road West Princeton NJ 08540
Generic Name: Somatropin Trade Name (if present): Genotropin Date Designated 9/6/1994 Date Approved 10/31/1997
Designation Approved:
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Pharmacia & Upjohn 7000 Portage Road Kalamazoo MI 49001-0199
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.
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Eli Lilly and Company Lilly Corporate Center Indianapolis IN 46285
Generic Name: Somatropin Trade Name (if present): Nutropin Date Designated 3/6/1987 Date Approved 10/17/1985
Designation Approved:
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Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco CA 94080
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.
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Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990
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.
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Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061
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.
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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 [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 [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).
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Pharmacia & Upjohn 7000 Portage Rd. 0633-298-113 Kalamazoo MI 49001-0199
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): 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 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): 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: 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: Sorafenib Trade Name (if present): Nexavar Date Designated 4/20/2006 Date Approved 11/16/2008
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 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: 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: 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: 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: Sulfadiazine Trade Name (if present):
Designation Approved:
Toxoplasmosis, as adjunctive with pyrimethamine
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Date Designated 3/14/1994 Date Approved 7/29/1994 Eon Labs Manufacturing, Inc. 227-15 North Conduit Avenue Laurelton NY 11413
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: 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: 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: 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: 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): 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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: 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