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)