Assay for simultaneous detection of 18 known genetic variants of human chtochrome gene, 2D6 and 2C19 (11/97)
Abbott Laboratories
HIVAG-1 monoclonal antibody
Abbott Laboratories
Diagnostic for use in blood banks and plasma centers, and for prognostic use in HIV patients (4/96)
Abbott Laboratories
Norvir
Abbott Laboratories
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.
-
-
Devices used for cell isolation and enrichment (8/96)
Advanced Magnetics Inc.
Feridex I.V.
Berlex Laboratories Inc.
To improve magnetic resonance scans of liver lesions in liver cancer (9/96)
Agouron Pharmaceuticals Inc.
Viracept
Glaxo Wellcome plc; Hoffmann-La Roche Ltd.
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.
Ditropan XL
Alza Corp. and UCB Pharma Inc.
15 mg tablets (alongside previously approved 5 mg and 10 mg formulations) for overactive bladder (6/99)
Alza Corp.
Doxil
Alza Corp.
Refractory ovarian cancer (6/99)
American Biogenetic Sciences Inc.
TpP Test
American Biogenetic Sciences Inc.
To aid in assessing risk of thrombosis and for monitoring efficacy of heparin therapy (10/96)
Amgen Inc.
Neupogen
Hoffmann-La Roche Ltd.; Amgen; 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)
Amgen Inc.
Epogen
Amgen Inc.
Treatment of anemia associated with chronic renal failure and anemia in Retrovir-treated HIV-infected patients (6/89); anemia cuased by chemotherapy in patients with nonmyeloid malignancies (4/93)
Consensus alpha interferon for hepatitis C (10/97)
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)
BioChem Pharma Inc.
3TC (Epivir)
Glaxo Wellcome plc
In combination with AZT for HIV infection and AIDS (11/95)
BioChem Pharma Inc.
Combivir
Glaxo Wellcome plc
Single-tablet formulation of 3TC and AZT for HIV (9/97)
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
Hepatitis B vaccine (9/89)
Biogen Inc.
Recombivax HB
Merck & Co. Inc.
Hepatitis B vaccine (7/86)
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)
Biomatrix Inc.
Synvisc
Wyeth-Ayerst Laboratories (unit of American Home Products Corp.)
Viscosuplementation treatment for arthritis of the knee (8/97)
Biomerica Inc.
TSH Test
Biomerica Inc.
Detection and monitoring of certain thyroid diseases (10/96)
Biomira Diagnostics Inc.
Truquant-BR
Biomira Inc.; Immunex Corp.
Diagnostic test for recurrence of breast cancer in women previously treated for stage II/III disease (4/96)
Biora AB
Emdogain
Biora Inc.
Enamel matrix protein-based treatment that initiates regrowth of tooth-supporting tissues lost due to periodontal disease (9/96)
Biota Holdings Ltd. (Australia)
Relenza
Glaxo Wellcome plc
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 Ingelheim Pharmaceuticals Inc. (division of Boehringer Ingelheim GmbH, Germany)
Viramune
Boehringer Ingelheim Pharmaceuticals Inc.
For use in combination with nucleoside analogues for treating HIV-infected adults (6/96)
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)
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)
Calypte Biomedical Corp.
HIV-1 Urine EIA
Seradyn Inc.
Diagnostic test for HIV infection (8/96)
CellPro Inc.
Ceprate SC System
CellPro Inc.
Separated cells returned to patient after chemotherapy or marrow-destroying procedures to restore bone marrow (12/96)
Centocor Inc.
ReoPro
Eli Lilly & Co.
To inhibit platelet aggregation in high-risk angioplasty (12/94)
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)
Connaught Laboratories Inc.
Tripedia
Connaught Laboratories Inc.
Vaccination of infants 2, 4 and 6 months of age and first booster at 15-20 months; primarily for whooping cough (7/96)
Connetics Corp.
Luxiq
Relief of inflammatory and pruritic manifestations of corticoid-responsive dermatoses of the scalp (3/99)
Cortecs International Ltd.
Helisal Rapid Blood
Boehringer Mannheim Diagnostics (unit of Corange Ltd., Bermuda; since acquired by Roche Holding Ltd., Switzerland)
Diagnostic for Helicobacter pylori infection (5/96)
COR Therapeutics Inc.
Integrilin
Schering-Plough Corp./ COR Therapeutics
Acute coronary syndrome and angioplasty (5/98)
Coulter Corp.
HIV-1 p24 Antigen Assay
-
Screening of donated blood at plasma and blood collection centers (3/96)
Cygnus Inc.
Nicotrol
Cygnus Inc.
Smoking cessation (7/96)
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.
OncoScint CR/OV
CIB bio-International
Detection, staging and follow-up of colorectal and ovarian cancers (12/92)
Cytogen Corp.
ProstaScint
Cytogen Corp.
Diagnostic imaging of prostate cancer in newly diagnosed patients; also for use in post-prostatectomy patients suspected of having occult metastatic disease (10/96)
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)
Diatide Inc.
AcuTect
Diatide/Nycomed Amersham plc
Scintigraphic imaging of acute venous thrombosis in the lower extremities (9/98)
Diatide Inc.
NeoTect
Diatide/Nycomed Amersham plc
Distinction of benign and malignant lung masses (8/99)
Digene Corp.
HPV Test
International Murex Technologies Corp.
DNA test detects presence of papillomavirus (1991)
Digene Corp.
Hybrid Capture II HPV DNA Test
Digene Corp.
Assay that detects DNA from 18 different human papillomavirus types (3/99)
Direct Access Diagnostics (subsidiary of Johnson & Johnson)
Confide
Blood collection kit (to test for antibodies to HIV-1)
Over-the-counter HIV home testing service; sample mailed to certified testing lab; service includes counseling and referral (5/96)
Duramed Pharmaceuticals Inc.
Genestin Tablets
Duramed Pharmaceuticals Inc.
Treatment of moderate-to severe vasomotor symptoms associated with menopause (3/99)
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)
Epitope Inc.
Orasure HIV-1 Western Blot Kit
SmithKline Beecham plc
For use in HIV testing with Orasure oral specimen collection device and assay (6/96)
G.D. Searle & Co. (a unit of Monsanto Co.)
Celebrex
G.D. Searle and Pfizer Inc.
Familial adenomatous polyposis (12/99)
GelTex Pharmaceuticals Inc.
Renagel
Genzyme General
Reduction of serum phosphorus in patients with end-stage renal disease (11/98)
Genentech Inc.
Roferon-A
Hoffmann-La Roche Inc. (unit of Roche Holdings Ltd.; Switzerland
Cystic fibrosis (12/93); treatment of cystic fibrosis in severely iill patients (less than 40% lung function) (12/96); treatment of cystic fibrosis in infants and young children (3/9)
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)
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)
Genetics Institute Inc. (subsidiary of American Home Products Corp.)
Recombinate
Baxter International Inc.
Blood clotting Factor VIII for hemophilia A (12/92)
Genetics Institute Inc. (subsidiary of American Home Products Corp.)
Neumega
Genetics Institute Inc.
Blood platelet booster (11/98)
Gen-Probe Inc.
Amplified Mycobacterium TB Test
Fisher Scientific Inc.
Tuberculosis test for smear-positive, previously untreated patients (12/95)
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.
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.
Carticel
Genzyme Corp.
Autologous cultured chonddrocytes to repair knee cartilage damage (8/97)
Genzyme Corp.
Thyrogen
Knoll Pharmaceutical Co.
Follow-up diagnostic for patients who have been treated for thyroid cancer (12/98)
Gilead Sciences Inc.
Vistide
Pharmacia & Upjohn Inc.
To delay progression of cytomegalovirus retinitis in AIDS patients (6/96)
Gilead Sciences Inc.
Tamiflu
Hoffmann-La Roche
Influenza A and B (10/99)
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)
HoffmannLa Roche Inc. (unit of Roche Holding Ltd.; Switzerland)
Roferon-A
Recombinant interferon alpha-2A
Chronic hepatitis C virus infection (11/96)
HoffmannLa Roche Inc. (unit of Roche Holding Ltd.; Switzerland)
Posicor
-
T-type calcium channel blocker (6/97)
Hemagen Diagnostics Inc.
DS DNA EIA
Elisa test to detect antibodies against human DNA
Diagnosis of lupus (12/96)
I.D. Biomedical Corp. (Canada)
Velogene Rapid MRSA Identification Assay
Alexon-Trend (subsidiary of Sybron International)
Antibiotic-resistant staph infections (7/99)
Idec Pharmaceuticals Corp.
Rituxan
Idec Pharmaceuticals Corp.
Monoclonal antibody for low-grade non-Hodgkin's lymphoma recurrences (11/97)
IGEN Inc.
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-
Test for detection and quantitation of residual DNA in biopharmaceutical products
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 hormone-refractory prostate cancer (in combination with steroids) (11/96)
Immunex Corp.
Enbrel
Wyeth-Ayerst Laboratories
Rheumatoid arthritis (10/98); severely active polyarticular-course juvenile rheumatoid arthritis (5/99)
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)
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)
Interneuron Pharmaceuticals Inc.
Redux
American Home Products Corp.
Obesity management (4/96); withdrawn from market 9/97 due to link with heart valve damage
Lark Technologies Inc.
Quantitative Polymerase Chain Reaction
-
Real-time detection system that increases the accuracy and sensitivity of quantitative RNA and DNA detection
Isis Pharmaceuticals Inc.
Vitravene
CIBA Vision Corp.
Treatment of cytomegalovirus retinitis in AIDS patients (8/98)
Ligand Pharmaceuticals Inc.
Simulect
Novartis AG
Acute rejection episodes in renal transplants (5/98)
Ligand Pharmaceuticals Inc.
Ontak
Ligand
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 Phamaceutical Inc.
Targretin
Ligand
Refractory cutaneous T-cell lymphoma (12/99)
Matritech Inc.
NMP22 Test Kit
UroCor Inc.; Wallac ADL GmbH
Assay to identify patients at risk for recurrence of bladder cancer (7/96)
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. (NYSE:AHP)
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)
Metra Biosystems Inc.
Pyrilinnks-D Assay
Metra Biosystems Inc.
Measures bone resorption (loss) to monitor bone diseases (1/96)
Metra Biosystems Inc. and Chiron Diagnostics Corp. (formerly CIBA Corning Diagnostics Corp.; subsidiary of Chiron Corp.; since acquired by Bayer AG)
ACS:Dpd
Metra Biosystems Inc. Chiron Diagnostics Corp.
Detection and management of osteoporosis and other metabolic bone diseases; to be used in combination with measurements of bone density (10/96)
Nabi and Cangene Corp.
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
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)
Novolin
Novo Nordisk A/S
Insulin-dependent diabetes mellitus (7/91)
Novo Nordisk A/S (Denmark)
Norditropin
Novo Nordisk A/S
Human growth hormone deficiency in children (5/95)
Novo Nordisk A/S (Denmark)
NovoSeven
Novo Nordisk A/S
Bleeding episodes in hemophiliacs (3/99)
Oncor Inc.
Sunrise Amplification Detection System
Oncor Inc.
Accomplishes nucleic acid amplification reactions in a closed-tube format
Organogenesis Inc.
Apligraf
Novartis AG
Venous leg ulcers (5/98)
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)
Ostex International Inc.
Osteomark NTx Serum Test
-
Prediction of skeletal response to antiresorptive therapy and in monitoring bone resorption changes following therapy (2/99)
To reduce flare-ups in relapsing multiple sclerosis (12/96)
The Liposome Co. Inc.
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)
TheraTech Inc.
Alora
TheraTech Inc.; Proctor and Gamble Co.
Estrogen therapy patch for menopausal symptoms (12/6)
Trinity Biotech plc (Ireland)
Uni-Gold Strep A test
-
Diagnosis of Streptococcus A infection (3/99)
Vysis Inc.
CEP8 Spectrum Orange DNA Probe Kit
Vysis Inc.
Diagnosis of leukemia (12/96)
U.S. Bioscience 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
HIV infection in children ages 4 and older, and in twice-daily dosage with other antiretrovirals for HIV infection (4/99)
Wyeth-Ayerst Laboratories (a division of American Home Products Corp.)
Rapamune
Wyeth-Ayerst Laboratories
Prevention of organ rejection following renal transplantation (9/99)
Zeneca Diagnostics Inc.
Elucigene
-
Detects 2 most common deficiency alleles of the alpha-1-antitrypsin gene, which is associated with development of emphysema and neonatal liver disease and cirhosis
Note: This chart is a broad overview of biotech and biotech-related products on the market in the U.S. 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.
Note: *Unless otherwise noted, companies were the original firms that obtained approval.
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