Company Product Description Indication Action/Date
Alza Corp. and Crescendo Pharmaceuticals Corp. Viadur Leuprolide acetate implant Advanced prostate cancer FDA approved Viadur (3/00)
Atrix Laboratories Inc. Atrisorb Freeflow & doxycycline Guided tissue regeneration barrier with the antibiotic doxycycline Periodontal surgery FDA approved Atrisorb with doxycycline (9/00)
Avanir Pharmaceuticals Inc. Abreva Docosanol 10% cream Cold sores and fever blisters FDA approved the cream as an over-the-counter remedy for cold sores and fever blisters (7/00)
Aventis Behring LLC Helixate Recombinant antihemophilic factor VIII Hemophilia A FDA approved helixate, a second-generation factor VIII formulated with sucrose for treatment of hemophilia A (6/00)
Aventis Pharmaceuticals Inc. Lantus Long-acting, once daily form of insulin glargine (rDNA origin) injection Type I and Type II diabetes Lantus was approved to treat adults with Type II diabetes and children with Type I (4/00)
BioChem Pharma Inc. Pacis BCG Immunotherapy Bladder cancer FDA approved Pacis BCG (3/00)
BioChem Pharma Inc. Trizivir Triple combination tablet, incorporates Biochem s 3TC/Epivir, plus abacavir sulphate and zidovudine HIV FDA approved Trizivir (11/00)
Biosite Diagnostics Inc. and Scios Inc. Triage BNP Test Test to measure Btype natriuretic peptide Diagnosis of congestive heart failure FDA approved the Triage BNP test (11/22)
Celltech ChiroScience Group (unit of Celltech Group plc; UK) Mylotarg Targeted chemotherapy agent Acute myeloid leukemia Company received approval to treat patients 60 years and older in first relapse with CD33-positive acute myeloid leukemia who are not considered candidates for cytotoxic chemotherapy (5/00)
Cell Therapeutics Inc. Trisenox Arsenic trioxide injection Acute promyelocytic leukemia FDA approved the drug to treat patients whose disease has recurred or who have failed to respond to standard therapy (9/00)
Connetics Corp. Olux Short-term topical treatments of the inflammatory and pruritic manifestations of dermatoses Moderate to severe corticoid-responsive dermatoses of the scalp FDA approved Olux (5/00)
Duramed Pharmaceuticals Inc. Cenestin tablets (FDAapproved) Plant-derived (soy and yams) synthetic conjugated estrogens Moderate to severe vasomotor symptoms associated with menopause FDA approved supplemental NDA for 1.25 mg dosage strength (3/00)
GelTex Pharmaceuticals Inc. Renagel Sevelamer hydrochloride; nonabsorbed polymer-based compound that binds to and eliminates target substances from the intestinal tract End-stage renal disease Renagel was approved to reduce serum phosphorus in hemodialysis patients with end-stage renal disease (7/00)
GelTex Pharmaceuticals Inc. Welchol Adjunctive therapy to diet and exercise Primary hypercholesterolemia Welchol was approved to reduce low-density lipoprotein cholesterol in patients with primary hypercholerolemia (5/00)
Genentech Inc. TNKase Tenecteplase; single-bolus thrombolytic Acute myocardial infarction TNKase was approved for marketing; it can be administered over five seconds in a single dose (6/00)
Genentech Inc. and InterMune Pharmaceuticals Inc. Actimmune Interferon gamma-1b Osteopetrosis Actimmune, already approved for chronic granulomatous disease, received approval to treat osteopetrosis (2/00)
Genetics Institute of Wyeth-Ayerst Laboratories (subsidiary of American Home Products Corp. ReFacto Recombinant antihemophiliac factor VIII Hemophilia A and short-term prophylaxis to reduce bleeding FDA approved ReFacto for control and prevention of bleeding and surgical prophylaxis with hemophilia A patients (3/00)
Gilead Sciences Inc. AmBisome Injectable liposomal formulation of aphotericin B Cryptococcal meningitis Company received a label expansion to treat cryptococcal meningitis in HIV-infected patients (7/00)
Immunex Corp. Enbrel Etanercept Early-stage rheumatoid arthritis FDA approved the expanded indication (6/00)
Immunex Corp. Novantrone Mitoxantrone Secondary progressive, progressive relapsingremitting multiple sclerosis FDA approved Novantrone for reducing neurological disability and/or the frequency of clinical relapses (10/00)
InKine Pharmaceutical Co. Inc. Visicol (formerly Diacol) Drug used for cleansing the bowel so doctors can view polyps and detect early colon cancer Bowel cleansing FDA approved Visicol (9/00)
Interneuron Pharmaceuticals Inc. Sarafem Fluoxetine hydrochloride (the same active ingredient found in Prozac) Premenstrual dysphoric disorder FDA approved Sarafem (7/00)
Ligand Pharmaceuticals Inc. Targretin Bexarotene; synthetic retinoid analogue that selectively activates X receptors Cutaneous T-cell lymphoma Targretin received approval to treat cutaneous lesions in patients with early stage cutaneous T-cell lymphoma who have refractory or persistent disease after other therapies or who have not tolerated other therapies (6/00)
Novo Nordisk A/S (Denmark) Norditropin Recombinant somatropin (human growth hormone) Growth failure Norditropin was approved for the long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone (6/00)
Organogenesis Inc. Apligraf Living, bi-layered skin substitute Diabetic foot ulcers FDA approved additional indication (6/00)
Protherics plc (UK) CroFab Antivenom consisting of antibody fragments derived by injecting rattlesnake venom into sheep and harvesting the antibodies Rattlesnake bites FDA approved CroFab (10/00)
QLT Phototherapeutics Inc. Visudyne Verteporfin; light-activated drug, used in photodynamic therapy Wet form of age-related macular degeneration Received FDA clearance (4/00)
Serono SA (France) Gonal-F Recombinant folliclestimulating hormone Infertility Gonal-F was approved to treat infertility in men and women (6/00)
Serono SA (France) Ovidrel Choriogonadotropin alfa for injection Infertility Ovidrel was approved to treat infertility due to anovulation and to promote final egg maturation in ovaries of women undergoing assisted reproductive technologies (10/00)
SkyePharma plc (UK) Solaraze Uses Hyaluronan Induced Targeting transdermal delivery technology Actinic keratosis FDA granted marketing approval (10/00)
Texas Biotechnology Corp. Acova Argatroban (formerly Novastan); injectable anticoagulant; direct thrombin inhibitor Thrombosis Argatroban was approved to prevent or treat thrombosis associated with heparininduced thrombocytopenia (6/00)
The Medicines Co. Angiomax Bivalirudin, anticoagulant Unstable angina FDA approved the marketing of Angiomax (12/00)