Company | Product | Marketer | Indication (U.S. Approval Date) |
Abbott Laboratories Inc. | HIVAG-1 monoclonal antibody | Abbott Laboratories Inc. | Diagnostic for use in blood banks and plasma centers, and for prognostic use in HIV patients (4/96) |
Abbott Laboratories Inc. | Norvir | Abbott Laboratories Inc. | Treatment of advanced AIDS (for use alone or in combination with nucleoside analogues); also treatment of earlier-stage AIDS (3/96) |
Activated Cell Therapy Inc. (now Dendreon Corp.) | Devices used for cell isolation and enrichment (8/96) | ||
Agouron Pharmaceuticals Inc. | Viracept | Glaxo Wellcome plc (UK); F. Hoffmann-La Roche Ltd. (Switzerland) | HIV protease inhibitor (3/97); twice-daily dosing for HIV (12/99) |
Alpha Therapeutic Corp. | AlphaNine SD | Alpha Therapeutic Corp. | To prevent and control bleeding due to Factor IX deficiency associated with hemophilia B (7/96) |
Alza Corp. | Doxil | Alza Corp. | Refractory ovarian cancer (6/99) |
Amgen Inc. | Epogen | Amgen Inc. | Treatment of anemia associated with chronic renal failure and anemia in AZT-treated HIV-infected patients (6/89); anemia caused by chemotherapy in patients with nonmyeloid malignancies (4/93) |
Amgen Inc. | Infergen | Amgen Inc.; Yamanouchi Pharmaceutical Co. Ltd. (Japan) | Consensus alpha interferon for hepatitis C (10/97) |
Amgen Inc. | Neupogen | F. Hoffmann-La Roche Ltd. (Switzerland); Amgen Inc.; Kirin Brewery Co. Ltd. (Japan) | Chemotherapy-induced neutropenia (2/91); bone marrow transplant (6/94); severe chronic neutropenia (12/94); support peripheral blood progenitor cell transplantation (12/95); acute myelogenous leukemia (4/98) |
Athena Neurosciences Inc. (subsidiary of Elan Corp. plc; Ireland) | Zanaflex | Athena Neurosciences Inc. | Spasticity associated with spinal cord injuries and multiple sclerosis (12/96) |
Atrix Laboratories Inc. | Atrisorb Barrier | Block Drug Co. | Periodontal disease (3/96); periodontal surgery (9/00) |
Avanir Pharmaceuticals Inc. | Abreva (Docosanol) | SmithKline Beecham plc (UK) | Cold sores and fever blisters (7/00) |
Aventis Behring LLC | Helixate | Aventis Behring LLC and Bayer Biological Products Business Unit | Helixate was approved for treatment of hemophilia A (2/94); second-generation factor VIII approved for treatment of hemophilia A (6/00) |
Aventis Pharmaceuticals Inc. | Lantus | Aventis Pharmaceuticals Inc. | Long-acting, once-daily form of insulin glargine (rDNA origin) injection for adults with Type II diabetes and children with Type I (4/00) |
BioChem Pharma Inc. | 3TC (Epivir) | Glaxo Wellcome plc (UK) | In combination with AZT for HIV infection and AIDS (11/95) |
BioChem Pharma Inc. | Combivir | Glaxo Wellcome plc (UK) | Single-tablet formulation of 3TC and AZT for HIV (9/97) |
BioChem Pharma Inc. | Pacis BCG | BioChem Pharma Inc. | Bladder cancer (3/00) |
BioChem Pharma Inc. | Trizivir | HIV (11/00) | |
Biocircuits Corp. | Biocircuits IOS TSH | Biocircuits Corp. | Primary screen for thyroid disease (11/96) |
Biogen Inc. | Avonex | Biogen Inc. | Multiple sclerosis (5/96) |
Biogen Inc. | Energix-B | SmithKline Beecham plc (UK) | Hepatitis B vaccine (9/89) |
Biogen Inc. | Intron-A | Schering-Plough Corp. | Hairy cell leukemia (6/86); genital warts (6/88); AIDS-related Kaposi s sarcoma (11/88); hepatitis C (2/91); hepatitis B (7/92); adjuvant with surgery in those with high risk of malignant melanoma recurrence (12/95); low-grade non-Hodgkin s lymphoma (11/97); hepatitis B in pediatric patients (8/98) |
Biogen Inc. | Recombivax HB | Merck & Co. Inc. | Hepatitis B vaccine (7/86) |
Biomatrix Inc. | Synvisc | Wyeth-Ayerst Laboratories (unit of American Home Products Corp.) | Viscosuplementation treatment for arthritis of the knee (8/97) |
Biota Holdings Ltd. (Australia) | Relenza | Glaxo Wellcome plc (UK) | Zanamivir for inhalation for treatment of influenza A and B (7/99) |
Bio-Technology General Corp. | BioTropin | Cannot sell in U.S. due to court injunction | Human growth hormone deficiency in children (5/95) |
BioTime Inc. | Hextend | Hypovolemia (3/99) | |
Boehringer Mannheim Corp. (division of Boehringer Mannheim GmbH; Germany) | Retavase | Centocor Inc. (acquired marketing rights from Boehringer Mannheim Corp. and Dupont Merck Pharmaceuticals Corp. in 1998) | Thrombolytic agent for acute myocardial infarction (10/96) |
Boehringer Mannheim Corp. | Viramune | Boehringer Ingelheim Pharmaceuticals Inc. | For use in combination with nucleoside analogues for treating HIV-infected adults (6/96) |
Bristol-Myers Squibb Co. | Zerit (d4T) | Bristol-Myers Squibb Co. | HIV infection; to be prescribed after patient has taken AZT for 6 months (1/96) |
Cell Therapeutics Inc. | Trisenox | Cell Therapeutics Inc. | Acute promyelocytic leukemia (9/00) |
CellPro Inc. | Ceprate SC System | CellPro Inc. | Separated cells returned to patient after chemotherapy or marrow-destroying procedures to restore bone marrow (12/96) |
Celltech Chiroscience Group (unit of Celltech Group plc; UK) | Mylotarg | Wyeth-Ayerst Laboratories (unit of American Home Products Corp.) | Targeted chemotherapy agent 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) |
Centocor Inc. | Remicade | Centocor Inc. | Crohn s disease (8/98); rheumatoid arthritis (11/99) |
Centocor Inc. | ReoPro | Eli Lilly & Co. | To inhibit platelet aggregation in high-risk angioplasty (12/94) |
Chiron Corp. | Betaseron | Berlex Laboratories Inc. | Relapsing, remitting multiple sclerosis (7/93) |
Chiron Corp. | Proleukin | Chiron Corp. | Renal cell carcinoma (5/92); metastatic melanoma (1/98) |
Chiron Corp. and OrthoClinical Diagnostics Inc. (unit of Johnson & Johnson) | RIBA HCV 3.0 Strip Immunoblot Assay | OrthoClinical Diagnostics Inc. | Confirmatory test for hepatitis C (2/99) |
Chiron Diagnostics (former business unit of Chiron Corp.; division acquired by Bayer AG in 1998) | ACS:180 DPD | Chiron Diagnostics; Metra Biosystems Inc. | Automated test for bone resorption (late 1996) |
Chiron Therapeutics (business unit of Chiron Corp.) and Ciba Pharmaceuticals (division of Ciba-Geigy Ltd., since merged with Sandoz Ltd. to form Novartis AG; Switzerland) | Aredia | Chiron Corp. | Treatment of metastatic bone disease in patients with breast cancer (used in conjunction with standard therapy) (8/96) |
Chiron Vision (unit of Chiron Corp.; division since acquired by Bausch & Lomb) | Vitrasert | Chiron Corp. | Cytomegalovirus retinitis infection in AIDS patients (3/96) |
Connetics Corp. | Luxiq | Connetics Corp. | Relief of inflammatory and pruritic manifestations of corticoid-responsive dermatoses of the scalp (3/99) |
Connetics Corp. | Olux | Connetics Corp. | Short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticoid-responsive dermatoses of the scalp (5/00) |
COR Therapeutics Inc. | Integrilin | Schering-Plough Corp.; COR Therapeutics Inc. | Acute coronary syndrome and angioplasty (5/98) |
Cypress Bioscience Inc. and Fresenius Hematology Inc. (subsidiary of Fresenius AG; Germany) | Prosorba Column | Cypress Bioscience Inc. | Moderate to severe rheumatoid arthritis (3/99) |
Cytogen Corp. | Quadramet | Cytogen Corp. | Radiopharmaceutical for pain associated with bone cancer (3/97) |
DepoTech Corp. (wholly owned subsidiary of SkyePharma plc; UK) and Chiron Corp. | DepoCyt | Chiron Corp. | Lymphomatous meningitis (4/99) |
Eli Lilly & Co. | Humalog | Eli Lilly & Co. | Diabetes (6/96) |
Eli Lilly & Co. | Humatrope | Eli Lilly & Co. | Human growth hormone deficiency in children (3/87); somatotropin deficiency syndrome in adults (8/96) |
Enzon Inc. | Adagen | Enzon Inc. | Treatment of infants and children with severe combined immunodeficiency (1990) |
Enzon Inc. | Oncospar | Rhone-Poulenc Rorer Inc. (subsidiary of RhonePoulenc Group; France) | Acute lymphoblastic leukemia (2/94) |
GelTex Pharmaceuticals Inc. | Renagel | Genzyme General | Reduction of serum phosphorus in patients with end-stage renal disease (11/98); reduction of serum phosphorus in hemodialysis patients with end-stage renal disease (7/00) |
GelTex Pharmaceuticals Inc. | Welchol | Sankyo Parke Davis | Adjunctive therapy to diet and exercise for the reduction of low-density lipoprotein cholesterol in patients with primary hypercholesterolemia (5/00) |
Genentech Inc. | Actimmune | InterMune Pharmaceuticals Inc. | Chronic granulomatous disease (12/90); treatment for severe malignant osteopetrosis (2/00) |
Genentech Inc. | Activase | Genentech Inc. | Acute myocardial infarction (11/87); acute pulmonary embolism (6/90); acute ischemic stroke (6/96); accelerated infusion (4/95); acute ischemic stroke within 3 hours of symptom onset (subset of adults whose strokes are caused by bleeding are not included in treatment group) (6/96) |
Genentech Inc. | Herceptin | Genentech Inc. | Metastatic breast cancer in combination with paclitaxel as a 1st-line agent and as single agent in women who have failed other therapies (9/98) |
Genentech Inc. | Humulin | Eli Lilly & Co. | Diabetes (10/82) |
Genentech Inc. | Kogenate | Bayer Corp. | Hemophilia A (12/93) |
Genentech Inc. | Nutropin AQ | Genentech Inc. | Growth failure associated with chronic renal insufficiency (11/93); growth hormone inadequacy (1/94); for treating children whose short stature is caused by growth hormone inadequacy or by chronic renal insufficiency (1/96); expanded label to include treatment of short stature in females with Turner s syndrome (12/96) |
Genentech Inc. | Protropin | Genentech Inc. | Growth hormone inadequcy; growth failure associated with chronic renal insufficiency (10/85) |
Genentech Inc. | Pulmozyme | Genentech Inc. | Cystic fibrosis (12/93); treatment of cystic fibrosis in severely ill patients (less than 40% lung function) (12/96); treatment of cystic fibrosis in infants and young children (3/98) |
Genentech Inc. | Roferon-A | Hoffmann-La Roche Inc. (unit of Roche Holdings Ltd.; Switzerland) | Hairy cell leukemia (6/86); AIDS-related Kaposi s sarcoma, Philadelphia chromosome positive chronic myelogenous leukemia (11/88) |
Genentech Inc. | TNKase | Genentech Inc. | Single-bolus thrombolytic for the treatment of acute myocardial infarction; can be administered over five seconds in a single dose (6/00) |
Genetics Institute of Wyeth-Ayerst Laboratories (unit of American Home Products Corp.) | Neumega | Genetics Institute of Wyeth-Ayerst Laboratories | Blood platelet booster (11/98) |
Genetics Institute of Wyeth-Ayerst Laboratories | Recombinate | Baxter International Inc. | Blood clotting Factor VIII for hemophilia A (12/92) |
Genetics Institute of Wyeth-Ayerst Laboratories | ReFacto | Genetics Institute of Wyeth-Ayerst Laboratories | FDA approved ReFacto for control and prevention of bleeding and surgical prophylaxis with hemophilia A patients (3/00) |
Gensia Laboratories Ltd. (subsidiary of Gensia Inc.) | Etoposide Injection | Gensia Laboratories Ltd. | Treatment of small-cell lung cancer and refractory testicular tumors (7/96) |
Genzyme Corp. | Carticel | Genzyme Corp. | Autologous cultured chonddrocytes to repair knee cartilage damage (8/97) |
Genzyme Corp. | Ceredase | Genzyme Corp. | Type I Gaucher s disease (4/91) |
Genzyme Corp. | Cerezyme | Genzyme Corp. | Type I Gaucher s disease (5/94) |
Genzyme Corp. | Seprafilm | Genzyme Corp. | To reduce postsurgical adhesions following open abdominal or pelvic surgery (8/96) |
Genzyme Corp. | Thyrogen | Knoll Pharmaceutical Co. | Follow-up diagnostic for patients who have been treated for thyroid cancer (12/98) |
Gilead Sciences Inc. | AmBisome | Fujisawa Healthcare Inc. (Japan) | Label expansion for injectable liposomal formulation of aphotericin B for treatment of cryptococcal meningitis in HIV-infected patients (7/00) |
Gilead Sciences Inc. | Tamiflu | F. Hoffmann-La Roche Ltd. (Switzerland) | Influenza A and B (10/99); flu prevention (11/00); influenza for children ages 1 to 12 (12/00) |
Gilead Sciences Inc. | Vistide | Pharmacia & Upjohn Inc. | To delay progression of cytomegalovirus retinitis in AIDS patients (6/96) |
Guilford Pharmaceuticals Inc. | Gliadel | Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc Group; France) | For use as adjunct to surgery to prolong survival of patients with recurrent glioblastoma multiforme (2nd-line therapy) (9/96) |
IDEC Pharmaceuticals Corp. | Rituxan | IDEC Pharmaceuticals Corp.; Genentech Inc. | Monoclonal antibody for low-grade non-Hodgkin s lymphoma recurrences (11/97) |
IGEN Inc. | Test for detection and quantitation of residual DNA in biopharmaceutical products | ||
Immunex Corp. | Enbrel | Wyeth-Ayerst Laboratories (unit of American Home Products Corp.) | Rheumatoid arthritis (10/98); severely active polyarticular-course juvenile rheumatoid arthritis (5/99); early stage rheumatoid arthritis (6/00) |
Immunex Corp. | Etoposide Injection | SuperGen Inc. | Treatment of refractory testicular tumors and smallcell lung cancer (3/96) |
Immunex Corp. | Leukine | Immunex Corp. | Neutropenia resulting from chemotherapy in acute myelogenous leukemia (9/95); bone marrow transplant engraftment or failure (11/95); peripheral blood stem cell mobilization (12/95); to stimulate production of white blood cells in patients undergoing bone marrow and peripheral blood progenitor cell transplants, and for treating chemotherapyinduced neutropenia (11/96) |
Immunex Corp. | Novantrone | Immunex Corp. | Treatment of acute nonlymphocytic leukemia (1987); treatment of hormone-refractory prostate cancer (in combination with steroids) (11/96); secondary progressive relapsing-remitting multiple sclerosis (10/00) |
Immunomedics Inc. | CEA-Scan | Mallinckrodt Inc. | In vivo diagnostic imaging agent to determine site and extent of colorectal cancer (for use in conjunction with standard diagnostic tests) (7/96) |
InKine Pharmaceutical Co. Inc. | Visicol (formerly Diacol) | InKine Pharmaceuticals Co. Inc. | Bowel cleansing for colonoscopy (9/00) |
Integra LifeSciences Corp. | Artificial Skin Dermal Regeneration Template | Integra LifeSciences Corp. | Treatment of full-thickness or deep partialthickness burns where conventional autograft is not available or desirable (to regenerate body s own dermis) (3/96) |
Integra LifeSciences Corp. | DuraGen DuralGraft Matrix | Integra LifeSciences Corp. | Dural closure in neurological procedures (7/99) |
Interferon Sciences Inc. | Alferon N Injection | The Purdue Frederick Co. | Genital warts (10/89) |
Isis Pharmaceuticals Inc. | Vitravene | CIBA Vision Corp. | Treatment of cytomegalovirus retinitis in AIDS patients (8/98) |
Ligand Pharmaceuticals Inc. | Ontak | Ligand Pharmaceuticals Inc. | Persistent or recurrent cutaneous T-cell lymphoma whose cells express the CD25 component of the IL-2 receptor (2/99) |
Ligand Pharmaceuticals Inc. | Panretin Gel | Integrated Commercialization Solutions | Dermal lesions in AIDS-related Kaposi s sarcoma (2/99) |
Ligand Pharmaceuticals Inc. | Simulect | Novartis AG (Switzerland) | Acute rejection episodes in renal transplants (5/98) |
Ligand Pharmaceuticals Inc. | Targretin | Ligand Pharmaceuticals Inc. | Refractory cutaneous T-cell lymphoma (12/99); 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) |
MedImmune Inc. | CytoGam | Connaught Laboratories Inc. | Prevention of cytomegalovirus in kidney transplant patients (11/91); prophylaxis against CMV disease associated with kidney, lung, liver, pancreas and heart transplants (12/98) |
MedImmune Inc. | RespiGam | American Home Products Corp. | Prevention of respiratory syncytial virus in children under 24 months of age with bronchopulmonary dysplasia or a history of premature birth (1/96) |
MedImmune Inc. | Synagis | MedImmune/Abbott Laboratories | Prevenetion of respiratory syncytial virus in children and infants (6/98) |
Merck & Co. Inc. | Crixivan | Merck & Co. Inc. | Treatment of adults with HIV infection, either as sole therapy or in combination with nucleoside analogues (3/96) |
Merck & Co. Inc. | Vioxx | Merck & Co. Inc. | Relief of signs and symptoms of osteoarthritis, management of acute pain in adults and treatment of menstrual pain (5/99) |
Nabi and Cangene Corp. (Canada) | Nabi-HB | Hepatitis B (3/99) | |
NeoRx Corp. | Verluma | Dupont Merck Pharmaceuticals Inc. (joint venture of E.I. Dupont & Co. and Merck & Co. Inc.) | In vivo diagnostic imaging agent used to determine extent of disease in patients diagnosed with smallcell lung cancer (8/96) |
Nexell Therapeutics Inc. | Isolex 300 Isolex 300i | Nexell Therapeutics Inc. | Ex vivo stem cell selection for patients undergoing high-dose chemotherapy and bone marrow transplants (7/99) |
NeXstar Pharmaceuticals Inc. | DaunoXome | Swedish Orphan AB (Sweden) | 1st-line therapy for Kaposi s sarcoma in AIDS patients (4/96) |
North American Vaccine | Certiva | Abbott Laboratories Inc. | Combined diphtheria, tetanus and acellular pertussis vaccine (8/98) |
Novo Nordisk A/S (Denmark) | Norditropin | Novo Nordisk A/S | Human growth hormone deficiency in children (5/95); recombinant somatropin (human growth hormone) for long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone (6/00) |
Novo Nordisk A/S (Denmark) | Novolin | Novo Nordisk A/S | Insulin-dependent diabetes mellitus (7/91) |
Novo Nordisk A/S (Denmark) | NovoSeven | Novo Nordisk A/S | Bleeding episodes in hemophiliacs (3/99) |
Organogenesis Inc. | Apligraf | Novartis AG (Switzerland) | Venous leg ulcers (5/98); living, bi-layered skin substitute for use in the treatment of diabetic foot ulcers (6/00) |
Ortho Biotech Inc. (unit of Johnson & Johnson) | Orthoclone OKT3 | Ortho Biotech Inc. | Reversal of acute kidney rejection (6/86); reversal of heart and liver transplant rejection (6/93) |
Pharmacia & Upjohn Inc. | Genotropin | Pharmacia & Upjohn | Growth hormone deficiency in children (8/95) |
Pharmacia & Upjohn Inc. | Fragmin | Pharmacia & Upjohn | Prevention of deep-vein thrombosis following hip replacement surgery (3/99); unstable angina and non-Q-wave myocardial infarction (5/99) |
ProCyte Corp. | Iamin Gel | Kissei Pharmaceutical Co. | Wound dressing and management (2/96) |
ProCyte Corp. | OsmoCyte Ultra Pillow Wound Dressing | ProCyte Corp. | Dressing for a variety of exudating chronic and acute wounds (both infected and noninfected) (12/96) |
Protherics plc (UK) | CroFab | Protherics plc | FDA approved CroFab, an antivenom to treat rattlesnake bites (10/00) |
QLT Phototherapeutics Inc. | Photofrin | Sanofi Winthrop Inc. | Advanced throat cancer (12/95) |
QLT Phototherapeutics Inc. | Visudyne | CIBA Vision Corp. | Wet form of age-related macular degeneration (4/00) |
Sequus Pharmaceuticals Inc. (subsidiary of ALZA Corp.) | Amphotec (aka Amphocil) | Sequus Pharmaceuticals Inc. | Invasive aspergillosis infections (2nd-line therapy) (11/96) |
Sequus Pharmaceuticals Inc. | Doxil | Sequus Pharmaceuticals Inc. | Refractory AIDS-related Kaposi s sarcoma (11/95) |
Serono SA (Switzerland) | Gonal-F | Serono Inc. | Infertility in women not due to primary ovarian failure (9/98); recombinant follicle-stimulating hormone for treatment of infertility in men and women (6/00) |
Serono SA (Switzerland) | Ovidrel | Serono Inc. | Infertility due to anovulation and promote final egg maturation in ovaries of women undergoing assisted reproductive technologies (10/00) |
Serono Laboratories Inc. (business unit of Ares-Serono Group; Switzerland) | Fertinex | Serono Laboratories Inc. | Infertility treatment (8/96); hormone deficiency (10/96) |
Serono Laboratories Inc. | Saizen | Serono Laboratories Inc. | Growth hormone deficiency in children (10/96) |
SkyePharma plc (UK) | Solaraze | SkyePharma plc | Actinic keratosis (10/00) |
Teva Pharmaceutical Industries Ltd. (Israel) | Copaxone | Teva Pharmaceutical Industries Ltd. | To reduce flare-ups in relapsing multiple sclerosis (12/96) |
Texas Biotechnology Corp. | Argatroban (formerly Novastan) | SmithKline Beecham plc (UK) | Anticoagulant for prevention of treatment of thrombosis associated with heparin-induced thrombocytopenia (6/00) |
The Liposome Co. Inc. (subsidiary of Elan Corp. plc; Ireland) | Abelcet | The Liposome Co. | Aspergillosis in those unable to take conventional drug (11/95); treatment of all types of confirmed or suspected invasive fungal infections (especially candidiasis) as 2nd-line therapy (10/96); severe systemic fungal infections (9/99) |
The Medicines Co. | Angiomax | Innovex Inc. | Unstable angina (12/00) |
U.S. Bioscience Inc. (subsidiary of MedImmune Inc.) | Ethyol | Alza Corp.; Southern Research Institute | To reduce kidney toxicity after chemotherapy for advanced ovarian cancer (12/95); to reduce the cumulative kidney toxicity of cisplatin in patients undergoing chemotherapy for non-small-cell lung cancer (3/96); moderate-to-severe post-operative, radiation-induced xerostomia in patients undergoing radiation treatment for head and neck cancer (6/99) |
Vertex Pharmaceuticals Inc. | Agenerase | Glaxo Wellcome plc (UK) | HIV infection in children ages 4 and older, and in twice-daily dosage with other antiretrovirals for HIV infection (4/99) |
Wyeth-Ayerst Laboratories (unit of American Home Products Corp.) | Rapamune | Wyeth-Ayerst Laboratories | Prevention of organ rejection following renal transplantation (9/99) |
Notes: This chart is a broad overview of biotech and biotech-related products on the market in the U.S. with an emphasis on therapeutic products. Not all of the companies represented are biotechnology firms. Large pharmaceutical companies are included when the products they developed address overwhelmingly important diseases such as AIDS and cancer, and where biotech companies are developing competing products. *Unless otherwise noted, companies were the original firms that obtained approval. | |||