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Current June 2001
Drug Name: Cytomegalovirus Immune Globulin (Cytogam)
Indication: To prevent cytomegalovirus infections in certain renal transplant
patients.
Sponsor: Commonwealth of Massachusetts, Department of Public Health
Allowed to Proceed Date: 10/19/87
Charge: Yes
Designated Orphan: Yes
Comment: Product License Application Approved on April 17, 1990, (MedImmune, Inc.)
Drug Name: Ifosfamide (Ifex) & Mesna (Mesnex)
Indication: Refractory germ cell carcinoma (mesna protects the bladder from
toxicity associated with ifosfamide treatment).
Sponsor: National Cancer Institute
Allowed to Proceed Date: 12/24/87
Charge: No
Designated Orphan: Yes
Group C: Yes
Comment: NDA Approved on December 31, 1988 (Bristol Myers Squibb)
Drug Name: Trimetrexate
Indication: Pneumocystis carinii pneumoinia in AIDS patients who cannot tolerate
standard forms of treatment.
Sponsor: National Institute of Allergy & Infectious Diseases
Allowed to Proceed Date: 02/18/88
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on on December 17, 1993, (U.S. Bioscience)
Drug Name: Anafranil (Clomipramine HCL)
Indication: Treatment of severe obsessive compulsive disorder.
Sponsor: Ciba-Geigy
Allowed to Proceed Date: 06/03/88
Charge: No
Designated Orphan: No
Comment: NDA Approved on December 29, 1989
Drug Name: Eldepryl (Selegilline HCL)
Indication: Treatment of severe Parkinson's disease unresponsive to standard
therapy.
Sponsor: Somerset Pharmaceuticals
Allowed to Proceed Date: 06/16/88
Charge: Yes
Designated Orphan: Yes
Comment: NDA Approved on June 5, 1989
Drug Name: Pentostatin (Nipent)
Indication: Treatment of hairy cell leukemia refractory to alpha interferon.
Sponsor: National Cancer Institute
Allowed to Proceed Date: 07/28/88
Charge: No
Designated Orphan: Yes
Group C: Yes
Comment: NDA Approved on October 11, 1991, (Supergen, Inc.)
Drug Name: Teniposide (Vumon)
Indication: Treatment of relapsed or refractory acute lymphoblastic leukemia.
Sponsor: National Cancer Institute
Allowed to Proceed Date: 10/07/88
Charge: No
Designated Orphan: Yes
Group C: Yes
Comment: NDA Approved on July 14, 1992, (Bristol Myers Squibb)
Drug Name: Ganciclovir (Cytovene)
Indication: Treatment of cytomegalovirus retinitis in AIDS patients
Sponsor: National Institute of Allergy & Infectious Diseases
Allowed to Proceed Date: 11/28/88
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on June 23, 1989, (Roche Laboratories)
Drug Name: Pentamidine Isethionate Aerosolized
Indication: Prevention of pneumocystis carinii pneumonia in AIDS patients.
Sponsor: LypoMed, Inc.
Allowed to Proceed Date: 02/03/89
Charge: Yes
Designated Orphan: Yes
Comment: NDA Approved on June 15, 1989
Drug Name: Levamisole Hydrochloride (Ergamisol)
Indication: For use (with 5-fluorouracil) as an adjuvant treatment for Dukes C
adenocarcinoma of the colon.
Sponsor: National Cancer Institute
Allowed to Proceed Date: 05/04/89
Charge: No
Designated Orphan: No
Group C: Yes
Comment: NDA approved on November 1, 1989, (Janssen Pharmaceuticals)
Drug Name: Erythropoietin (EPO)
Indication: Treatment of zidovudine (AZT) related anemia in HIV positive patients.
Sponsor: Ortho
Allowed to Proceed Date: 06/27/89
Charge: No
Designated Orphan: No
Comment: Product License Application Approved on December 31, 1990
Drug Name: Exosurf (synthetic pulmonary surfactant)
Indication: Prevention and treatment of Respiratory Distress Syndrome (RDS) in
premature infants.
Sponsor: Burroughs Wellcome
Allowed to Proceed Date: 07/26/89
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on August 2, 1990
Drug Name: Dideoxyinosine (ddI)
Indication: Treatment of patients with AIDS or AIDS Related Complex who are
intolerant to zidovudine (AZT).
Sponsor: Bristol Myers Squibb
Allowed to Proceed Date: 09/28/89
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on October 9, 1991
Drug Name: Survanta (bovine pulmonary surfactant)
Indication: Prevention and treatment of Respiratory Distress Syndrome (RDS) in
premature infants.
Sponsor: Ross Laboratories
Allowed to Proceed Date: 09/29/89
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on July 1, 1991
Drug Name: Retrovir (zidovudine)
Indication: Treatment of pediatric patients with HIV disease
Sponsor: Burroughs Wellcome
Allowed to Proceed Date: 10/26/89
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on May 2, 1990
Drug Name: Ceredase (beta-glucocerebrosidase)
Indication: Chronic enzyme replacement therapy in the management of patients with
Gaucher's disease (Type 1).
Sponsor: Genzyme Corporation
Allowed to Proceed Date: 11/07/89
Charge: Yes
Designated Orphan: Yes
Comment: NDA Approved on April 5, 1991
Drug Name: Fludarabine phosphate (Fludra)
Indication: Chronic Lymphocytic leukemia.
Sponsor: National Cancer Institute
Allowed to Proceed Date: 11/24/89
Charge: No
Designated Orphan: Yes
Group C: Yes
Comment: NDA Approved on April 22, 1991, (Berlex Labs)
Drug Name: Lioresal (Baclofen) Intrathecal
Indication: Spasticity in patients with multiple sclerosis or spinal cord injury
who are intolerant to or unresponsive to oral baclofen (03/90) and spastiality of cerebral
origin (12/94).
Sponsor: Medtronic
Allowed to Proceed Date: 03/07/90 and 12/12/94
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on June 17, 1992
Drug Name: Granulocyte Macrophage Colony Stimulating Factor (GMCSF)
Indication: Bone-marrow transplantation graft delay or failure.
Sponsor: Immunex Corp.
Allowed to Proceed Date: 09/24/90
Charge: No
Designated Orphan: Yes
Comment: Product License Application Approved on March 6, 1991
Drug Name: Dideoxycytidine (ddC)
Indication: Treatment of patients with AIDS or advanced ARC who cannot be
maintained on zidovudine (AZT).
Sponsor: Hoffmann-La Roche
Allowed to Proceed Date: 05/30/91
Charge: No
Designed Orphan: Yes
Comment: NDA Approved on June 19, 1992
Drug Name: 4-Hydroperoxycyclophosphamide (4HC)
Indication: Bone marrow purging.
Sponsor: Nova Pharmaceutical
Allowed to Proceed Date: 06/14/91
Charge: Yes
Designated Orphan: Yes
Comment: None
Drug Name: Oxandrolone
Indication: Clinical management of boys with constitutional delay of growth and
puberty (10/91) and in girls with Turners Syndrome (10/92).
Sponsor: Gynex, Inc.
Allowed to Proceed Date: 10/17/91 and 10/21/91
Charge: Yes
Designated Orphan: Yes
Comment: None
Drug Name: Mepron (Atovaquone)
Indication: Treatment of AIDS patients with Pneumocystis carinii pneumonia who are
intolerant to or unresponsive to trimethoprim/sulfamethoxazole.
Sponsor: Burroughs Wellcome
Allowed to Proceed Date: 11/08/91
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on November 27, 1992
Drug Name: Cognex (Tacrine) (THA)
Indication: Treatment of patients with Alzheimer's dementia.
Sponsor: Parke-Davis
Allowed to Proceed Date: 12/02/91
Charge: Yes
Designated Orphan: No
Comment: NDA Approved on September 9, 1993
Drug Name: Mycobutin (Rifabutin)
Indication: Prophylaxis against Mycobacterium Avium Complex bacteremia in
HIV-infected patients.
Sponsor: Adria Laboratories
Allowed to Proceed Date: 03/06/92
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on December 23, 1992
Drug Name: 2-Chlorodeoxyadenosine (2-CdA)
(Leustatin)
Indication: Treatment of active hairy cell leukemia.
Sponsor: National Cancer Institute
Allowed to Proceed Date: 03/06/92
Charge: No
Designated Orphan: Yes
Group C: Yes
Comment: NDA Approved on February 26, 1993, (Ortho Biotech)
Drug Name: Taxol (paclitaxel)
Indication: Treatment of advanced refracotry epithelial ovarian cancer.
Sponsor: National Cancer Institute
Allowed to Proceed Date: 07/15/92
Charge: No
Designated Orphan: No
Group C: Yes
Comment: NDA Approved on December 29, 1992, (Bristol Myers Squibb)
Drug Name: Copolymer-1 (COP-1)
Indication: Treatment of exacerbating-remitting Multiple Sclerosis.
Sponsor: Teva/Lemmon
Allowed to Proceed Date: 01/05/93
Charge: Yes
Designated Orphan: Yes
Comment: NDA Approved on December 20, 1996
Drug Name: Glucophage (Metformin HCL)
Indication: Non-insulin dependent Diabetes Mellitus.
Sponsor: Lipha Pharmaceuticals
Allowed to Proceed Date: 09/10/93
Charge: Yes
Designated Orphan: No
Comment: NDA Approved on December 29, 1994
Drug Name: Navelbine (Vinorelbine tartrate)
Indication: Non-small cell lung cancer.
Sponsor: Burroughs Wellcome
Allowed to Proceed Date: 04/14/94
Charge: No
Designated Orphan: No
Comment: NDA (non-small cell lung cancer) Approved on December 23, 1994
Drug Name: Somatropin
Indication: Treatment of AIDS-associated catabolism/weight loss.
Sponsor: Serono Laboratories
Allowed to Proceed Date: 12/20/94
Charge: Yes
Designated Orphan: Yes
Comment: NDA Approved on August 23, 1996
Drug Name: Gemcitabine Hydrochloride
Indication: Locally advanced or metastatic pancreatic cancer.
Sponsor: Lilly Research Laboratories
Allowed to Proceed Date: 01/27/95
Charge: No
Designated Orphan: No
Comment: NDA Approved on May 15, 1996
Drug Name: Atorvastatin
Indication: Homozygous familial hypercholesterolemia or severe refractory
hypercholesterolemia.
Sponsor: Parke-Davis
Allowed to Proceed Date: 02/09/95
Charge: No
Designated Orphan: No
Comment: NDA Approved on December 17, 1996
Drug Name: Riluzole
Indication: Amyotrophic Lateral Sclerosis (ALS).
Sponsor: Rhone-Poulenc Rorer
Allowed to Proceed Date: 06/20/95
Charge: No
Designated Orphan: Yes
Comment: NDA Approved on December 12, 1995
Drug Name: Vistide (Cidofovir)
Indication: Treatment of CMV Retinitis
Sponsor: Gilead Sciences, Inc
Allowed to Proceed Date: 09/01/95
Charge: No
Designated Orphan: No
Comment: NDA Approved on June 26, 1996
Drug Name: Autologous Peripheral Blood Lymphocytes
Activated Ex Vivo with OKT3 Monoclonal Antibody
Indication: Treatment of Metastatic (Stage IV) Renal Cell Carcinoma.
Sponsor: Cellcor
Allowed to Proceed Date: 09/15/95
Charge: Yes
Designated Orphan: No
Comment: None
Drug Name: Carmustine Wafer
Indication: Recurrent malignant glioma.
Sponsor: Guilford Pharmaceuticals
Allowed to Proceed Date: 10/27/95
Charge: Yes
Designated Orphan: No
Comment: NDA Approved on September 23, 1996
Drug Name: Myotrophin
Indication: Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Cephalon, Inc.
Allowed to Proceed Date: 06/19/96
Charge: No
Designated Orphan: Yes
Comment: On May 12, 1998, FDA issued an "approvable" letter to the
sponsors. The letter does not constitute an approval of the drug, but does provide details
on what additional steps the manufacturer needs to take in order to gain approval.
Drug Name: Progesterone Gel
Indication: Invitro Fertilizations (IVF).
Sponsor: Columbia Research, Inc.
Allowed to Proceed Date: 02/07/97
Charge: No
Designated Orphan: No
Comment: NDA Approved on May 13, 1997
Drug Name: Xyrem (sodium oxybate)
Indication: For the treatment of narcolepsy
Sponsor: Orphan Medical Inc.
Allowed to Proceed Date: 12/16/98
Charge: Yes
Designated Orphan: Yes
Comment: Still under investigation