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) |