Acute promyelocytic leukemia in patients unable to take oral formulation of tretinoin
FDA withdrew invitation to Aronex to discuss its Atragen new drug application (NDA) at the Oncologic Drugs Advisory Committee on Sept. 17 due to deficiencies in the NDA filing (8/5)
Avanir Pharmaceuticals
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N-docosanol 10% cream; long-chain fatty acid that interferes with viral entry into cells
Treatment of oralfacial herpes
Company representatives met with the FDA's Division of Dermatological and Dental Products to discuss 3/99 response to notapprovable letter received 12/98 (3/8; 3/18); FDA requested additional statistical analyses to assess consistency of clinical data (7/26); submitted additional clinical data (8/4); received notification that application for approval required additional data (9/16); FDA provided preliminary results of the company's appeal regarding its NDA (11/1)
Cell Pathways Inc.
Aptosyn (formerly Prevatac)
Exisulind; cyclic GMP phosphodiesterase inhibitor
Adenomatous polyposis coli
Submitted NDA (8/26) FDA accepted the company's new drug application (10/25)
Centocor Inc. (a subsidiary of Johnson & Johnson)
Remicade (FDAapproved)
Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha
Prevention of joint damage in patients with rheumatoid arthritis
Ciba Vision Corp. (a unit of Novartis AG, Switzerland) and QLT Phototherapeutics Inc.
Visudyne
Verteporfin; light-activated drug for photodynamic therapy
Treatment of wet agerelated macular degeneration (AMD) in patients with predominately classic subfoveal choroidal neovascularization
Submitted NDA (8/16)
Coherent Inc. and QLT PhotoTherapeutics Inc. Coulter Pharmaceutical Inc. and SmithKline Beecham plc
Visudyne Bexxar
Verteporfin; light-activated drug for photodynamic therapy Iodine I-131 tositumomab; murine monoclonal antibody against CD20 antigen on B cells, labeled with I-131
Wet form of AMD Relapsed or refractory, low-grade or transformed lowgrade B-cell nonHodgkin's lymphoma
FDA granted priority review status to joint device/drug application (8/27) Submitted BLA (6/30); Received priority review status (7/22); FDA requested modifications to biologics license application (8/30)
Crescendo Pharmaceuticals Corp. and Alza Corp.
Viadur (a.k.a. DUROS leuprolide)
Leuprolide acetate implant; drug-filled, miniature titanium implant that continuously delivers leuprolide for a full year
Palliative treatment of advanced prostate cancer
Submitted NDA (5/26)
Elan Corp. plc (Ireland)
NeuroBloc
Botulinum toxin type B (inhibits transmission of acetylcholine); intramuscluar injection
Cervical dystonia
Submitted PLA (1/11)
Ergo Science Corp.
Ergoset tablets
Low-dose, oral formulation of bromacriptine (ergot alkaloid; generic dopamine agonist
Treatment of Type II diabetes
Ergo said it would appeal not-approvable letter sent 11/98 (3/19)
GelTex Pharmaceuticals Inc.
Cholestagel
Cholesterol reducer, nonabsorbed hydrogel that binds to and eliminates bile acids from the intestinal tract
Hypercholesterolemia
Submitted NDA (7/30)
Genelabs Technologies Inc.
GL701
Dehydroepiandosterone; (naturally occurring hormone produced by the adrenal glands)
Systemic lupus erythematosus
FDA deemed the company's NDA adequate for submission (11/22)
Sulesomab; monoclonal antibody fragment labeled with technetium-99 that binds to white blood cells
Various infectious diseases
FDA informed the company of deficiencies in its product filing (11/29)
InKine Pharmaceutical Co. Inc.
Diacol
Sodium phosphate tablets
Adult patients undergoing colonoscopic evaluation
Submitted NDA (11/23)
InterMune Pharmaceuticals Inc.
Actimmune (FDAapproved)
Interferon gamma 1-b
Osteopetrosis
Filed BLA (8/23)
Ligand Pharmaceuticals Inc.
Targretin gel
1% topical formulation of bexarotene
Early-stage cutaneous T-cell lymphoma
Filed new drug application (12/9)
Medeva plc (UK)
Hepagene
3rd-generation recombinant vaccine that incorporates all 3 hepatitis B virus surface antigens (pre-S1, pre-S2 and S)
Vaccine for hepatitis B virus infection
Submitted BLA (2/10); FDA said more information is needed before the agency can accept licensing application; areas of question include the number of subjects in the clinical database for safety evaluation and various manufacturing issues (4/12)
NeXstar Pharmaceuticals Inc. and Fujisawa Healthcare Inc. (a subsidiary of Fujisawa Pharmaceutical Co. Ltd., Japan)
AmBisome (FDAapproved)
Unilamellar liposomal formulation of amphotericin B
Cryptococcal meningitis in AID patients
Submitted supplemental new drug application (7/12)
Novo Nordisk A/S (Denmark)
85/15 PenFill Cartridges
Mixture of 85% NPH, human insulin isophane suspension (rDNA origin) and 15% regular, human insulin injection (rDNA origin); contained in 3 ml cartridges that are designed for use with NovoPen 3 insulin delivery device
Diabetes mellitus
Submitted NDA (4/19)
Novo Nordisk A/S (Denmark)
Norditropin SimpleXx
Somatropin (rDNA origin) liquid growth hormone for subcutaneous injection
Long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone
Submitted NDA (7/1)
Organogenesis Inc.
Apligraf
Living human skin equivalent, composed of living human keratinocytes and fibroblasts
Diabetic foot ulcers
Filed premarket approval application (12/22)
Ortec International Inc.
Composite Cultured Skin
Tissue-engineered dressing consisting of two layers of human-derived skin cells (dermal and epidermal) supported with a porous collagen matrix
Protherics plc (formed through the merger of Proteus International plc and Therapeutic Antibodies Inc.; UK)
DigiTAb
Antidote to digoxin poisoning
Digoxin toxicity
FDA accepted product license application and establishment license application (10/13)
SangStat Medical Corp.
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Generic azathioprine; immunosuppressant that inhibitis development of T cells by interfering with the differentiation and proliferation of activated lymphocytes
Adjunct therapy for prevention of organ transplant rejection
Abbreviated NDA filed (6/14)
Scotia Holdings plc (UK)
Foscan
Photodynamic cancer therapeutic
Various cancers
NDA accepted for review (12/2)
Shaman Pharmaceuticals Inc.
Provir
Oral formulation of compound SP-303, which is isolated from the croton plant; it is thought to act by inhibiting secretion of chloride from intestinal cells
AIDS-related diarrhea
Held pre-NDA meeting with FDA, after which the company said it is reviewing its filing strategy (could include labeling change and more trials) (1/27)
Shire Pharmaceuticals Group plc and Janssen Pharmaceutica (Belgium)
Galantamine (Reminyl)
An inhibitor of an enzyme that breaks down the neurotransmitter acetylcholine, and acts on the brain's nicotinic receptors
Alzheimer's disease
Submitted application for marketing approval (9/29)
SuperGen Inc.
Nipent (FDAapproved)
Pentostatin for injection; chemotherapeutic drug that inhibits adenosine deaminase (blocks DNA synthesis)
Treatment of various mature T-cell lymphomas, particularly cutaneous T-cell lymphoma and peripheral T-cell lymphoma
Filed supplemental NDA for new indications (2/26)
Texas Biotechnology Corp. and SmithKline Beecham
Novastan
Synthetic molecule (argatro-ban) derived from arginine; acts as direct inhibitor of thrombin
Heparin-induced thrombocytopenia syndrome
Submitted corrected amendment to NDA (8/23)
The Ares-Serono Group (Switzerland)
Rebif
Recombinant interferon beta-1a
Multiple sclerosis
Received complete response letter to BLA, asking for clarification of clinical information and data, and stating Rebif may not be approved while orphan exclusivity remains in effect for Biogen Inc.'s Avonex or Chiron Corp.'s Betaseron (3/1)
The Liposome Co. Inc.
Evacet
Liposomal formulation of doxorubicin
Metastatic breast cancer (combination therapy with cyclophosphamide)
NDA accepted for filing (2/18); withdrew NDA following consultation with the FDA regarding issues raised by the Oncologic Drugs Advisory Committee; the company expects to resubmit the NDA