Company Product Description Indication Action/Date
Agouron Pharmaceuticals Inc. (a subsidiary of the WarnerLambert Co.) Viracept (FDAapproved) Nelfinavir mesylate; synthetic small-molecule HIV protease inhibitor HIV infection FDA approved twice-daily dosing based on Phase III trial results (12/1)
Alkermes Inc. and Genentech Inc. Nutropin Depot Sustained-release formulation of Genentech's recombinant growth hormone based on Alkermes' ProLease injectable delivery system (administered once or twice a month) Growth hormone deficiency in children Approved (12/26)
Alza Corp. Ditropan XL (FDAapproved) Oxybutynin chloride extended-release tablets (via OROS osmotic drugdelivery technology); tablet formulation Overactive bladder Agency cleared 15 mg tablets for marketing (alongside previously approved 5 mg and 10 mg formulations) (6/24)
Alza Corp. Doxil (FDAapproved) Doxorubicin liposome injection formulation Refractory ovarian cancer Cleared for marketing (6/29)
Biota Holdings Ltd. (Australia) Relenza (zanamivir for inhalation) Zanamivir, neuriminidase inhibitor (designed and synthesized based on crystal structure of surface proteins of influenza virus); inhaled in powder form Treatment of influenza A and B Cleared for marketing (7/28)
BioTime Inc. Hextend Blood plasma volume expander Treatment of hypovolemia Cleared for marketing (3/31)
Centocor Inc. (a subsidiary of Johnson & Johnson Co.) Remicade (FDAapproved) Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha Rheumatoid arthritis Received marketing approval (11/10)
Chembio Diagnostic Systems PreVue B. burgdorferi Antibody Detection Assay Point-of-care test for Lyme disease bacteria (B. burgdorferi) using recombinant antigenic proteins Initial test for Lyme disease, to be used in conjunction with confirmatory Western Blot test Cleared for marketing (2/16)
Chiron Corp. and OrthoClinical Diagnostics Inc. (unit of Johnson & Johnson) RIBA HCV 3.0 Strip Immunoblot Assay 3-step test uses 5 proteins that react to hepatitis C antibodies in the blood; previous version of test used 4 proteins Confirmatory test for hepatitis C viral infection Cleared for marketing (2/12)
Connetics Corp. Luxiq Betamethasone valerate foam, 0.12%; stabilized foam formulation of midpotency steroid Relief of inflammatory and pruritic manifestations of corticoidresponsive dermatoses of the scalp Cleared for marketing (3/2)
Cypress Bioscience Inc. and Fresenius Hematology Inc. (subsidiary of Fresenius AG; Germany) Prosorba column Disposable filter that uses Protein A to remove immune complexes from patient¿s blood Treatment of moderateto-severe rheumatoid arthritis Cleared for marketing (3/16)
DepoTech Corp. (wholly owned subsidiary of SkyePharma plc; UK) and Chiron Corp. DepoCyt Injectable, sustainedrelease formulation of chemotherapeutic agent cytarabine; uses DepoFoam (lipid-based drug) Lymphomatous meningitis (complication of nonHodgkin¿s lymphoma) Cleared for marketing (4/5)
Diatide Inc. and Nycomed Amersham Imaging NeoTect Technetium Tc-99m depreotide injection; a novel peptide-based imaging agent Distinction of benign and malignant lung masses Cleared for marketing (8/4)
Digene Corp. Hybrid Capture II HPV DNA Test Assay that detects DNA from 18 different human papillomavirus types Detection of human papillomavirus Cleared for marketing (3/19)
Duramed Pharmaceuticals Inc. Cenestin tablets Plant-derived (soy and yams) synthetic complex mixture conjugated estrogens product Treatment of hot flashes, night sweats and other moderate-tosevere vasomotor symptoms associated with menopause Cleared for marketing (3/25)
G.D. Searle & Co. Inc. (a unit of Monsanto Co.) Celebrex Celecoxib; COX-2 enzyme inhibitor Familial adenomatous polyposis FDA granted adjunctive treatment approval (12/23)
Gilead Sciences Inc. and Hoffmann-La Roche Inc. (the U.S. subsidiary of F. Hoffmann-La Roche; Switzerland) Tamiflu Oseltamivir phosphate; antiviral neuraminidase inhibitor Influenza A & B Received marketing approval (10/28)
ID Biomedical Corp. (Canada) Velogene Rapid MRSA Identification Assay Diagnostic test enabling accurate identification of methicillin-resistant Staphylococcus aureus Antibiotic-resistant staph infections Cleared for marketing (7/14)
Immunex Corp. and Wyeth-Ayerst Laboratories division of American Home Products Corp. Enbrel (FDAapproved) Etanercept; recombinant, soluble p75 tumor necrosis factor (TNFr) linked to the Fc portion of human IgG1 Severely active polyarticular-course juvenile rheumatoid arthritis Cleared for marketing in additional indication (5/28)
Integra LifeSciences Corp. DuraGen DuralGraft Matrix Collagen matrix for the restoration of the dura mater; provides a scaffold for the infiltration of fibroblasts and a substrate for the deposition of new collagen Method of dural closure in neurological procedures Received 510(k) clearance (7/8)
Ligand Pharmaceuticals Inc. Ontak (denileukin difitox, DAB389IL-2) Fusion protein consisting of a fragment of diphtheria toxin genetically fused to interleukin-2; targets IL-2 receptors on the surface of malignant cells and some normal lymphocytes, leading to the death of those cells Persistent or recurrent cutaneous T-cell lymphoma whose cells express the CD25 component of the IL-2 receptor Cleared for marketing (2/5)
Ligand Pharmaceuticals Inc. Targretin Synthetic retinoid analogue Treatment of all stages of refractory cutaneous T-cell lymphoma Cleared for marketing (12/29)
Ligand Pharmaceuticals Inc. Panretin Gel Alitretinoin 0.1% (topical); chemically synthesized version of 9-cis-retinoic acid (derived from vitamin A) Treatment of dermal lesions in AIDS-related Kaposi¿s sarcoma Cleared for marketing (2/3)
Merck & Co. Inc. Vioxx Rofecoxib; specific inhibitor of cyclooxygenase-2 Relief of signs and symptoms of osteoarthritis, management of acute pain in adults and treatment of menstrual pain Cleared for marketing (5/21)
Nabi and Cangene (Canada) Nabi-HB Hepatitis B immune globulin (human, plasma-derived, 5% protein formulation); product undergoes solvent/ detergent filtration and nanofiltration Treatment following exposure to hepatitis B virus Cleared for marketing (3/25)
Nexell Therapeutics Inc. Isolex 300 and Isolex 300i Magnetic cell selection systems for the selection of hematopoietic stem cells and the removal of tumor cells from autologous peripheral blood Ex vivo stem cell selection for patients undergoing highdose chemotherapy and bone marrow transplants Cleared for marketing (7/6)
Novo Nordisk A/S (Denmark) NovoSeven Recombinant factor VIIa Treatment of bleeding episodes in hemophiliacs whose bodies reject other coagulation factors Cleared for marketing (3/26)
Ostex International Inc. Osteomark NTx Serum Test Quantitative measure of cross-linked N-telopeptides of type 1 collagen (NTx) in serum as an indicator of human bone collagen breakdown (resorption) Prediction of skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following therapy Cleared for marketing (2/8)
Pharmacia & Upjohn Fragmin (FDAapproved) Dalteparin sodium injection; low-molecular-weight heparin Prevention of deep-vein thrombosis following hip replacement surgery Cleared for marketing (3/31)
Pharmacia & Upjohn Fragmin (FDAapproved) Dalteparin sodium injection; low molecular weight heparin Unstable angina and non-Q-wave myocardial infarction Cleared for marketing (5/26)
Roche Molecular Systems (unit of Roche Holding AG; Switzerland) Amplicor HIV-1 Monitor Ultrasensitive assay; quantitates HIV-1 RNA levels down to 50 copies per ml of plasma (uses PCR amplification) Measurement of viral load (circulating virus) in HIV-infected patients (used to prove efficacy of anti-retroviral therapies) Cleared for marketing (3/3)
Sepracor Inc. Xopenex Levalbuterol HCL inhalation solution; therapeutically active (R)-isomer of racemic albuterol; in 2 dosage strengths for use with a nebulizer Treatment and prevention of bronchospasm Cleared for marketing (3/26)
The Liposome Co. Inc. Abelcet injection Complex of amphotericin B with two phospholipids Severe, systemic fungal infections Cleared for marketing (9/2)
Trinity Biotech plc (Ireland) Uni-Gold Strep A test Qualitative assay for Strep A antigen, which can be carried out directly on throat swabs Diagnosis of Streptococcus A infection Cleared for marketing (3/15)
U.S. Bioscience and Alza Corp. Ethyol (FDAapproved) Amifostine; selective cytoprotective agent Moderate-to-severe post-operative, radiation-induced xerostomia in patients undergoing radiation treattreatment for head and neck cancer Cleared for marketing (6/24)
Vertex Pharmaceuticals Inc. and Glaxo Wellcome plc Agenerase Amprenavir; 2nd-generation HIV protease inhibitor; twice-daily dosage HIV infection in children ages 4 and older, and in adults in combination with other antiretrovirals for HIV infection Cleared for marketing (4/20)
Wyeth-Ayerst Laboratories (a division of American Home Products Corp.) Rapamune Sirolimus; an immunosuppressant agent that inhibits the activation of TOR (target of rapamycin), a regulatory kinase involved in cell cycle progression Prevention of organ rejection following renal transplantation Received marketing approval (9/15)