| Company (Symbol) | Product | Description | Indication | Action (Date) |
| Advanced Tissue Sciences Inc. (ATIS) and Smith & Nephew plc (NYSE:SNN) | Dermagraft | Human tissue-engineered replacement for dermal layer of skin (viable human dermal fibroblasts, derived from foreskins, cultured) | Diabetic foot ulcers | FDA approved application for amendment to IDE application; amendment modifies study inclusion criteria to limit future enrollment to patients with ulcers of greater than six weeks duration (2/29); company submitted a a premarket approval application to the FDA (8/25) |
| Amgen Inc. (AMGN) | NESP; novel erythropoiesis-stimulating protein | Renal disease | Submitted NDA (1/25) | |
| Amgen Inc. (AMGN) | Kineret | Recombinant form of the cytokine interleukin-1ra, which selectively blocks the effects of IL-1, a cytokine released as part of the disease process in rheumatoid arthritis | Rheumatoid arthritis | Filed BLA (1/25) |
| Amylin Pharmaceuticals Inc. (AMLN) | Symlin | Pramlinitide acetate; synthetic analogue of human pancreatic hormone amylin | Type I and Type II diabetes | Company submitted an NDA to market Symlin as an adjunctive therapy to insulin (12/7) |
| Aronex Pharmaceuticals Inc. (ARNX) | Atragen | Liposomal formulation of tretinoin (all trans-retinoic acid) | Acute promyelocytic leukemia | Submitted amendment to NDA for patients who need therapy with tretinoin but for whom an intravenous administration is required (7/6); FDA accepted for review the company s amendment to its NDA (8/21) |
| Aviron (AVIR) and American Home Products Corp. (NYSE:AHP) | FluMist | Intranasal vaccine | Influenza | Companies filed a BLA with the FDA for FluMist to prevent influ enza in children and adults (10/31); FDA accepted for review the BLA (12/29) |
| Celgene Corp. (CELG) | d-MPH | d-methylphenidate; chirally pure version of Ritalin | Attention deficit disorder and attention deficit hyperactivity disorder | FDA accepted for filing the NDA (12/27) |
| CollaGenex Pharmaceuticals Inc. (CGPI) | Periostat (new formulation of FDA-approved drug) | Small, film-coated tablet containing 20mg doxycycline hyclate, which inhibits production of collagenase | Adjunctive treatment of adult periodontitis | Filed NDA (3/31) |
| Coulter Pharmaceutical Inc. (CLTR) and SmithKline Beecham plc (NYSE:SBH) | Bexxar | Tositumomab, iodine tositumomab; radioimmunotherapy involving antibody conjugated to iodine-131 | Relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin s lymphoma | Company resubmitted BLA (9/18); FDA assigned priority review status to Bexxar (10/5); FDA accepted for filing the BLA (11/14) |
| Enzon Inc. (ENZN) and Schering-Plough Corp. (NYSE:SGP) | PEG-Intron Powder for Injection | Long-acting dosage form of Schering-Plough s Intron A (re-combinant interferon alfa-2b) conjugated to polyethylene glycol | Chronic hepatitis C virus infection in adults with compensated liver disease | Submitted biologics license application (BLA) (1/5); BLA accepted for review (2/10) |
| Genelabs Technologies Inc. (GNLB) | GL701 | Dehydroepiandosterone (DHEA), a naturally occurring hormone produced by the adrenal glands | Systemic lupus erythematosus | Began submission of NDA using rolling process in accordance with fast-track designation (5/31); company submitted its NDA for marketing approval (9/26) |
| Genelabs Technologies Inc. (CNLB) | Aslera (FDA-approved) | GL701 or prasterone | Systemic lupus erythematosu | FDA granted priority review s status to the Aslera NDA (10/25) |
| Genentech Inc. (NYSE:DNA), Tanox Inc. (TNOX) and Novartis Pharmaceuticals Corp. (unit of Novartis AG; Switzerland; NYSE:NVS) | Recombinant humanized monoclonal antibody to immunoglobulin E | Asthma and allergy | Submitted BLA (6/5) | |
| Genentech Inc. (NYSE:DNA) | Alteplase | Recombinant, a bioengineered version of the naturally occurring tissue plasminogen activator | To open occluded central venous access devices | Company submitted a supplemental BLA to restore function of devices necessary to withdraw or infuse vital fluids to ill patients (10/2) |
| Genzyme General (GENZ) | Fabrazyme | Agalsidase beta; enzyme replacement therapy | Fabry disease | Filed BLA (6/23); FDA accepted the BLA for Fabrazyme; Genzyme said FDA said there is no need for a December advisory committee review of the BLA for Fabrazyme (11/1); FDA completed its review of the BLA and requested additional data (12/26) |
| Gliatech Inc. (GLIA) | Adcon-P | Adhesion control barrier; resorbable carbohydrate polymer liquid | Prevention of post-surgical scarring following gynecological pelvic surgery | FDA agreed to review product under PMA modular review process and accepted first module (4/6); FDA accepted second module (4/20) |
| Gliatech Inc. (GLIA) | Adcon-L (FDA-approved) | Anti-adhesion barrier gel (semisynthetic carbohydrate polymer) surgery | Inhibition of post-surgical scarring and adhesions following back | Company commented on FDA s Form 483 report on irregularities in clinical trial used to support PMA; Gliatech launched a task force of executives and researchers not involved in the trial to investigate; the company also said it would respond to the items cited in the Form 483 within 15 days (8/29); Gliatech withdrew its PMA supplement in response to the FDA s concerns and has proposed re-evaluating the MRI data (10/16) |
| Gliatech Inc. (GLIA) | Adcon-P; Adcon-L (FDA-approved) | Gel to inhibit postsurgical scarring | Postsurgical scarring | FDA sent the company a letter questioning its methods of recording and presenting clinical trial data; it suspended review of three premarket approval applications - two Adcon-L supplemental applications and the modular submission for Adcon-P (12/23) |
| Glaxo Wellcome plc (NYSE:GLX) and Biota Holdings Ltd. | Relenza | Zanamivir; neuraminidase inhibitor | Influenza strains A and B | Company submitted application for expanded approval (9/18) |
| ICN Pharmaceuticals Inc. (NYSE:ICN) and Schering-Plough Corp. (NYSE:SGP) | Rebetol (FDA-approved) | Oral formulation of ribavirin | Hepatitis C | Schering-Plough submitted a supplemental NDA to the FDA seeking approval to market Rebetol separately and used in combination with Intron A injection (12/15) |
| IDEC Pharmaceuticals Corp. (IDPH) | Rituxan (FDA-approved) | Rituximab; genetically engineered chimeric pan B monoclonal antibody that targets CD20 antigen on B-cell surface | Non-Hodgkin s lymphoma | Company received a completed review letter from FDA regarding a supplemental BLA (9/27) |
| IDEC Pharmaceuticals Corp. (IDPH) | Zevalin | Ibritumomab tiuxetan; radioimmuno-therapeutic | B-cell non-Hodgkin s lymphoma | Company submitted a BLA to the FDA; FDA granted fast-track designation (11/1) |
| Ilex Oncology Inc. (ILXO), Millennium Pharmaceuticals Inc. (MLNM) and Berlex Laboratories (unit of Schering AG; Germany) | Campath | Alemtuzumab; humanized monoclonal antibody that specifically targets and binds to CD52 cell surface antigen on lymphocytes | B-cell lymphocytic leukemia | FDA advisory panel review at the panel s Dec. 14 meeting resulted in a recommendation for accelerated approval(12/14); BLA was submitted in December 1999 (10/26); BLA accepted for filing (2/15); companies submitted response in answer to FDA s 6/23 complete response letter, which addressed the 12/99 BLA for the product (8/21) |
| Lifecore Biomedical Inc. (LCBM) | Intergel Adhesion Prevention Solution | Combines hyaluranon and iron to create ferric hyaluranon | Reduction of post-surgical adhesion formation after certain pelvic abdominal procedures | Filed amendment to PMA in response to decision of General and Plastic Surgery Advisory Panel's decision not to recommend approval (6/5); company will pursue formal dispute resolution with Medical Devices Dispute Resolution Panel (12/20) |
| Ligand Pharmaceuticals Inc. (LGND) and Elan Corp. plc (Ireland; NYSE:ELN) | Morphelan | Once-daily, modified-release, oral dosage form of morphine | Management of pain in oncology and HIV patients | Elan filed NDA for the product, to be marketed by Ligand (6/8) |
| The Liposome Company Inc. (subsidiary of Elan Corp. plc; Ireland) | Evacet | Liposomal formulation of doxorubicin | Metastatic breast cancer | Met with FDA officials to discuss additional analyses submitted at the end of 1999 with an NDA; eye toward resubmission of original NDA withdrawn 10/99 (2/3) |
| Matrix Pharmaceutical Inc. (MATX) | IntraDose Injectable Gel | Biodegradable gel containing cisplatin and epineephrine (intra-tumoral injection) | Squamous cell | Submitted initial section of NDA carcinoma (4/3); orphan drug status granted (4/13); submitted second portion of NDA (7/5) |
| Orphan Medical Inc. (ORPH) | Xyrem | Sodium oxybate; oral formulation | Narcolepsy | Submitted an NDA to treat the symptoms of narcolepsy (10/2); FDA granted priority review status (10/17); FDA accepted the NDA for filing (12/4) |
| OraPharma Inc. (OPHM) | MPTS | Minocycline periodontal therapeutic system; microsphere encapsulated formulation of the antibiotic minocycline | Periodontitis | NDA accepted for review (4/26) |
| Praecis Pharmaceuticals Inc. (PRCS) and Amgen Inc. (AMGN) | Abarelix depot-M | Gonadotropin-releasing hormone antagonist | Prostate cancer | Companies submitted an NDA (12/13) |
| QLT PhotoTherapeutics Inc. (QLTI) and CIBA Vision Corp. (CIBA) | Visudyne (FDA-approved) | Photodynamic therapy activated by specially designed laser that produces low-level non-thermal 689 nm light | Ocular conditions characterized by choroidal neovas-cularization | Companies filed a supplemental NDA for Visudyne to treat eye diseases beyond age-related macular degeneration (8/14); granted priority review status (8/29) |
| Scotia Pharmaceuticals plc (UK; LSE:SOH) | Foscan | Photodynamic therapy | Head and neck cancer | FDA is allowing the company to submit an amended NDA including 83 additional patients studied (12/6) |
| Sepracor Inc. (SEPR) and Schering-Plough Corp. (NYSE:SGP) | Desloratadine | Antihistamine, nonsedating disintegrating tablet | Seasonal allergic rhinitis and chronic idiopathic urticaria | Schering-Plough submitted NDAs for two formulations of desloratadine (12/13) |
| Shearwater Polymers Inc. and F. Hoffmann La Roche Ltd. (Switzerland) | Pegasys | Peginterferon alfa-2a; once-weekly injection of pegylated version of interferon alfa-2a | Chronic hepatitis C in patients with compensated liver disease | Submitted BLA (5/22) |
| Sonus Pharmaceuticals Inc. (SNUS) | Echogen | Perflenapent injectable emulsion; fluorocarbon-based ultrasound contrast agent | Improved assessment of the left ventricle during echocardiograph | Company responded to issues raised in FDA's 3/00 request for re-analysis of certain data (5/23) |
| Texas Biotechnology Corp. (AMEX:TXB) and SmithKline Beecham plc (NYSE:SBH) | Argatroban | Anticoagulant; synthetic direct thrombin inhibitor that blocks the activity of thrombin | Heparin-induced thrombocytopenia | Companies submitted a supplemental NDA to expand the use of Argatroban (12/21) |
| Transkaryotic Therapies Inc. (TKTX) andAventis Pharma AG (unit of Aventis SA; France; NYSE:AVE) | Dynepo (formerly GA-EPO) | Gene-activated erythropoietin; gene in human cells is activated in situ to produce EPO | Anemia in patients with chronic renal failure | Aventis filed in the U.S. and Europe for marketing approval (8/3) |
| Transkaryotic Therapies Inc. (TKTX) | Replagal | Agalsidase alfa; enzyme replacement therapy | Fabry disease | Submitted BLA (6/16) |
| United Therapeutics Corp. (UTHR) | Uniprost (formerly UT-15) | Subcutaneous prostacyclin therapy; stable structural analogue of prostacyclin | Pulmonary hypertension | Submitted initial sections of NDA (8/14); company filed an NDA (10/16); FDA granted priority review status (10/19); FDA accepted NDA for filing (11/3); FDA said the UT-15 NDA will be reviewed before the Cardiovascular and Renal Drugs Advisory Committee at a meeting in early 2001 (11/8) |
| Visible Genetics Inc. (VGIN) | Trugene HIV-1 Genotyping Kit and OpenGene DNA sequencing system | Designed to genetically decode the highly mutagenic HIV-1 from patient serum, identify mutations and indicate a treatment regimen | To identify genetic mutations in the HIV virus | Company submitted its application to the FDA (9/5) |
| Vivus Inc. (VVUS) | Alibra | Urethral microsuppository of alprostadil and prazosin hydrocholoride | Erectile dysfunction | Company withdrew its NDA and plans to meet with the FDA to determine the additional data needed; company also plans to meet with the European Agency for the Evaluation of Medicinal Products concerning the pending European application (10/20) |
| Zonagen Inc. (ZONA) and Schering-Plough Corp. (NYSE:SGP) | Vasomax | Immediate-release, oral formulation of phentolamine mesylate | Erectile dysfunction | FDA said an additional animal study would be required before agency could consider approval; FDA recommended two-year rodent study due to concerns about brown fat proliferations observed in earlier rat study; Zonagen is appealing (5/16) |
