Assay for simultaneous detection of 18 known genetic variants of human cytochrome gene, 2D6 and 2C19
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)
Alpha Therapeutic Corp.
AlphaNine SD
Alpha Therapeutic Corp.
To prevent and control bleeding due to Factor IX deficiency associated with hemophilia B (7/96)
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 caused by chemotherapy in patients with non-myeloid 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. (NASDAQ:BLOCA)
Periodontal disease (3/96)
BioChem Pharma Inc.
3TC (Epivir)
Glaxo Wellcome plc (NYSE:GLX; U.K.)
In combination with AZT for HIV infection and AIDS (11/95)
BioChem Pharma Inc.
Combivir
Glaxo Wellcome plc (NYSE:GLX; U.K.)
Single-tablet formulation of 3TC and AZT for HIV (9/97)
Biocircuits Corp. (Company now out of business)
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 Beechman plc (NYSE:SKB; U.K.)
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.; NYSE:AHP)
Viscosupplementation 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)
Bio-Technology General Corp.
BioTropin
Cannot sell in U.S. due to court injunction
Human growth hormone deficiency in children (5/95)
Boehringer Ingelheim Pharmaceuticals Inc. (division of Boehringer Ingelheim GmbH, Germany)
Viramune
Boehringer Ingelheim Pharmaceuticals Inc.
For use in combination with nucleo-side 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 and Co.
To inhibit platelet aggregation in high-risk angioplasty (12/94)
Centocor Inc.
Remicade
Centocor Inc.
Crohn¿s disease (8/98)
ChemTrak Inc.
Hp Chek
Astra Merck
Point-of-care diagnostic assay for Helicobacter pylori (7/96)
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; NYSE: BOL)
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)
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)
Cytogen Corp.
OncoScint
CIB bio-International CR/OV
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)
Diatide Inc.
AcuTect
Diatide/Nycomed Amersham plc
Scintigraphic imaging of acute venous thrombosis in the lower extremeties (9/98)
Digene Corp.
HPV Test
International Murex Technologies Corp.
DNA test detects presence of papillomavirus (1991)
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)
Eli Lilly and Co. (NYSE:LLY)
Humalog
Eli Lilly and Co.
Diabetes (6/96)
Eli Lilly and Co. (NYSE:LLY)
Humatrope
Eli Lilly and 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 Rhone-Poulenc Group; France)
Acute lymphoblastic leukemia (2/94)
Epitope Inc.
Orasure HIV-1 Western Blot Kit
SmithKline Beechman plc
For use in HIV testing with Orasure oral specimen collection device and assay (6/96)
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 Holding Ltd.; Switzerland)
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.
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. NYSE:AHP)
Recombinate
Baxter International Inc. (NYSE:BAX)
Blood clotting Factor VIII for hemophilia A (12/92)
Genetics Institute Inc. (subsidiary of American Home Products Corp. NYSE:AHP)
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 chondrocytes 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.; U.K.
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)
Hoffmann-La Roche Inc. (unit of Roche Holding Ltd.; Switzerland)
Roferon-A
Recombinant interferon alpha-2A
Chronic hepatitis C virus infection (11/96)
Hoffmann-La 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)
Idec Pharmaceuticals Corp.
Rituxan
Idec Pharmaceuticals Corp.
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.
Etoposide Injection
SuperGen Inc.
Treatment of refractory testicular tumors and small-cell 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 chemotherapy-induced 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)
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 partial-thickness burns where conventional autograft is not available or desirable (to regenerate body¿s own dermis) (3/96)
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)
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
Prevention of respiratory syncytial virus in children and infants (6/98)
Merck & Co. Inc. (NYSE:MRK)
Crixivan
Merck & Co. Inc.
Treatment of adults with HIV infection, either as sole therapy or in combination with nucleoside analogues (3/96)
Metra Biosystems
Pyrilinks-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)
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 small-cell lung cancer (8/96)
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)
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; NYSE:J&J)
Orthoclone OKT3
Ortho Biotech Inc.
Reversal of acute kidney rejection (6/86); reversal of heart and liver transplant rejection (6/93)
Ortho Biotech Inc. (unit of Johnson & Johnson; NYSE:J&J)
Procrit
Ortho Biotech Inc.
Anemia associated with chronic renal failure and anemia in Retrovir-treated AIDS patients (12/90); anemia caused by chemotherapy in patients with non-myeloid malignancies (4/93); Procrit was approved for marketing under expanded label for use in anemic patients scheduled to undergo elective non-cardiac, non-vascular surgery (12/96)
Pacific Pharmaceuticals Inc.
PocketWatch
Steri-Oss
Periodontal tissue monitor kit
Penederm Inc.
Mentax
Penederm Inc.
Interdigital tinea pedis (athlete¿s foot) (10/96)
Pharmacia & Upjohn Inc.
Genotropin
Pharmacia &Upjohn
Growth hormone deficiency in children (8/95)
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 noninfected and infected) (12/96)
QLT Phototherapeutics Inc.
Photofrin
Sanofi Winthrop Inc.
Advanced throat cancer (12/95)
Quidel Corp.
QuickVue
Quidel Corp.
Test for Helicobacter pylori infection (2/96)
Quidel Corp.
Strep Throat Test
Quidel Corp.
Quick test for strep throat (4/96)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc Group; France)
Taxotere
Rhone-Poulenc Rorer Inc.
Treatment of locally advanced or metastatic breast cancer which is resistant to or recurred after anthracycline chemotherapy (5/96)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc Group; France)
Rilutek
Rhone-Poulenc Rorer Inc.
Lou Gehrig¿s disease (12/95)
Roche Molecular Systems (unit of Roche Holding Ltd.; Switzerland)
Amplicor HIV-1 Monitor Test
Hoffmann-La Roche Ltd.
Indicator of disease progression in AIDS patients (6/96)
Sequus Pharmaceuticals Inc.
Doxil
Sequus Pharmaceuticals Inc.
Refractory Kaposi¿s sarcoma in AIDS patients (11/95)
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)
TheraTech Inc.
Alora
TheraTech Inc.; Proctor and Gamble Co.
Estrogen therapy patch for menopausal symptoms (12/96)
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)
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 cirrhosis
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