Company Product Description Indication Action/Date
Advanced Polymer Systems Inc. - Microsponge-entrapped 5-fluorouracil Actinic keratoses Submitted new drug application (NDA) (11/1)
Alza Corp. and Crescendo Pharmaceuticals Corp. Oros methylphenidate Once-daily treatment combining methylphenidate with Alza's Oros osmotic drug delivery technology Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder Submitted NDA (7/21)
Aronex Pharmaceuticals Inc. Atragen Liposomal formulation of all trans-retinoic acid 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 - 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 Submitted supplemental biologics license application (10/18)
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)
Genentech Inc. Tenecteplase Recombinant plasminogen activator Heart attack Submitted BLA (8/2)
Gilead Sciences Inc. - Adefovir dipivoxil; reverse transcriptase inhibitor (oral) HIV-infected patients with disease progression despite prior reverse transcriptase inhibitor therapy Submitted NDA (6/29)
Ilex Oncology Inc., Millennium Pharmaceuticals Inc. and Berlex Laboratories (a unit of Schering AG, Germany) Campath Alemtuzumab, humanized monoclonal antibody B-cell chronic lymphocytic leukemia Filed biologics license application (12/23)
Immunex Corp. Enbrel (FDAapproved) Etanercept; recombinant, soluble p75 tumor necrosis factor (TNFr) linked to the Fc portion of human IgG1 Early, active rheumatoid arthritis Filed supplemental biologics license application (7/15)
Immunex Corp. Novantrone (FDAapproved) Mitoxantrone for intravenous injection Secondary progressive multiple sclerosis Received priority review status (7/19)
Immunomedics Inc. LeukoScan 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 Epidermolysis Bullosa, StevensJohnson Syndrome, Toxic Epidermal Necrolysis, Erythema Multiforme Filed for marketing approval (11/22)
Palatin Technologies Inc. LeuTech Antibody-based infection imaging agent Diagnosis of equivocal appendicitis Submitted biologics license application (11/23)
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. - 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
Therapeutic Antibodies Inc. (UK) Digitab Antidote to digoxin poisoning Digoxin intoxication Submitted product license application (PLA) and establishment license application (ELA) (8/9)
Unimed Pharmaceuticals Inc. Androgel Gel-based product for transdermal administration of testosterone Low testosterone levels in hypogonadal men Submitted NDA (4/29)
Vanguard Medica Group plc (UK) and Elan Corp plc (Ireland) Frovatriptan 5HT 1B/1D agonist Treatment of migraine NDA accepted for review (3/26)
Zonagen Inc. and ScheringPlough Corp. Vasomax Immediate-release, oral formulation of phentolamine mesylate Erectile dysfunction Companies opted to forgo June advisory panel review of NDA until results of additional studies can be submitted (5/10)