| Company
| Product
| Marketer
| Indication
|
| Affymetrix Inc.
| GeneChip cytochrome P450 assay
| Affymetrix Inc.
| 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.
| HIV protease inhibitor Hoffman LaRoche Ltd. (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
| Hoffman-La Roche Ltd.; Amgen; Kirin Brewery Co. Ltd.
| Chemotherapy-induced neutropenia (2/91); bone marrow transplant (6/94) severe chronic neutropenia (12/94); support peripheral blood progenitor cell transplantation (12/95)
|
| 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)
|
| Amgen Inc.
| Infergen
| Amgen Inc; Yamanouchi Pharmaceutical Co. Ltd.
| Consensus alpha interferon for hepatitis C (10/97)
|
| Athena
| Zanaflex
| Athena
| Spasticity associated with spinal
|
| Neurosciences Inc. (subsidiary of Elan Corp plc; Ireland)
|
| Neurosciences Inc.
| cord injuries and multiple sclerosis (12/96)
|
| Atrix Laboratories Inc.
| Atrisorb Barrier
|
| 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 Beechman 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)
|
| Biomatrix Inc.
| Synvisc
| Wyeth-Ayerst Laboratories (unit of American Home Products)
| Viscosupplementation treatment for arthritis of the knee
|
| 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
| Boehringer Mannheim Corp.; DuPont Merck Pharmaceuticals Corp.
| 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 chemo- therapy 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)
|
| ChemTrak Inc.
| Hp Chek
| Astra Merck
| Point-of-care diagnostic assay for Helicobacter pylori (7/96)
|
| Chiron Corp.
| Betaseron Proleukin
| Berlex Laboratories Inc. Chiron Corp.
| Relapsing, remitting multiple sclerosis (7/93) Renal cell carcinoma (5/92)
|
| Chiron Diagnostics (business unit of Chiron Corp.)
| ACS:180 DPD
| Chiron Diagnostics; Metra Biosystems Inc.
| Automated test for bone resorption (late 1996)
|
| Chiron Therapeutics (business unit of Chiron Corp.) and Ciba Pharma- ceuticals (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 stand- ard therapy) (8/96)
|
| Chiron Vision (Unit of Chiron Corp.)
| 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 Inter- national Ltd.
| Helisal Rapid Blood
| Boehringer Mannheim Diagnostics (unit of Corange Ltd.; Bermuda)
| Diagnostic for Helicobacter pylori infection (5/96)
|
| 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 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)
|
| Digene Corp.
| HPV Test
| International Murex Technologies Corp.
| DNA test detects presence of papillomavirus
|
| 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.
| Humalog
| Eli Lilly and Co.
| Diabetes (6/96)
|
| Eli Lilly and Co.
| 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)
|
| Genentech Inc. .
| Roferon-A
| Hoffmann-La Roche Inc. (unit of Roche Holding Ltd.; Switzerland)
| Hairy cell leukemia (6/86); AIDS-related Kaposi's sarcoma, Philadelphia chromosome positive chronic myelogenous leukemia (11/88)
|
| Genentech Inc.
| Pulmozyme
| Genentech Inc.
| Cystic fibrosis (12/93); treatment of cystic fibrosis in severely ill patients (less than 400ng function) (12/96)
|
| 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
| Genetech Inc.
| Growth hormone inadequacy; growth failure associated with chronic renalinsufficiency (10/85)
|
| Genentech Inc.
| Humulin
| Eli Lilly and Co.
| Diabetes (10/82)
|
| Genentech Inc.
| Actimmune
| Genetech Inc.
| Chronic granulomatous disease (12/90)
|
| Genentech Inc.
| Activase
| Genetech Inc.
| Acute myocardial infarction (11/87); acute pul- monary 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)
|
| Genetics Institute Inc. (subsidiary of American Home Products Corp.)
| Recombinate
| Baxter International Inc.
| Blood clotting factor VIII for hemophilia A
|
| Genetics Institute Inc. (subsidiary of American Home Products Corp.)
| Neumega
| Genetics Institute Inc.
| Blood platelet booster
|
| Gen-Probe Inc.
| Amplified Mycro- bacterium 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 (1991)
|
| Genzyme Corp.
| Cerezyme
| Genzyme Corp.
| Type I Gaucher's disease (5/94)
|
| Genzyme Corp.
| Seprafilm
| Genzyme Corp.
| To reduce post-surgical adhesions following open abdominal or pelvic surgery (8/96)
|
| Genzyme Corp.
| Carticel
| Genzyme Corp.
| Autologous cultured chondrocytes to repair knee cartilage damage (8/97)
|
| 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 inter- feron 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 trans- plant 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)
|
| 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 Life Sciences Corp.
| Artificial Skin Dermal Regeneration Template
| Integra LifeSciences Corp.
| Treatment of full-thickness or deep partial-thickness burns where conventional auto-graft 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 increases the accuracy and sensitivity of quantitatve RNA and DNA detection
|
| 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)
|
| MedImmune Inc.
| RespiGam
| American Home Products Corp.
| For prevention of respiratory syncitial virus in children under 24 months of age with bronchopulmonary dysplasia or a history of premature birth (1/96)
|
| 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)
|
| Metra Biosystems Inc.
| 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.)
| ACS:Dpd
| Metra Biosystems Inc.; Chiron Diagnostics Corp.
| Detection and management of osteoporosis and other metabolic bone diseases; to be used in com- bination with measurements of bone density (10/96)
|
| NeoRx Corp.
| Verluma
| Dupont Merck Pharmaceuticals Inc.
| In vivo diagnostic imaging agent used to determine extent of disease in patients diagnosed with small cell lung cancer (8/96)
|
| NeXstar Pharm- aceuticals Inc.
| DaunoXome
| Swedish Orphan AB
| 1st line therapy for Kaposi's sarcoma in AIDS patients (4/96)
|
| Novo Nordisk A/S
| Novolin
| Novo Nordisk A/S
| Insulin-dependent diabetes mellitus (7/91)
|
| Novo Nordisk A/S
| Norditropin
| Novo Nordisk A/S
| Human growth hormone deficiency in children (5/95)
|
| Oncor Inc. Johnson)
| Sunrise Amplification
| Oncor Inc.
| Accomplishes nucleic acid amplification reactions in a closed-tube format 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 Pharma- ceuticals 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 Photo- therapeutics 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
| Hoffman-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)
|
| Sequus Pharmaceuticals Inc.
| Amphotec (a.k.a. Amphocil)
| Sequus Pharmaceuticals Inc.
| Treatment of invasive aspergillosis infections (2nd-line therapy) (11/96)
|
| Serono Laboratories Inc. (business unit of Ares-Serono Group; Switzerland)
| Saizen
| Serono Laboratories Inc.
| Treatment of children with growth hormone deficiency (10/96)
|
| Serono Laboratories Inc. (business unit of Ares-Serono Group; Switzerland)
| Serostim
| Serono Laboratories Inc.
| AIDS wasting (cachexia) in adults (8/96)
|
| Serono Laboratories Inc. (business unit of Ares-Serono Group; Switzerland)
| Fertinex
| Serono Laboratories Inc.
| Infertility treatment (8/96) hormone deficiency (10/96)
|
| Teva Pharmaceutical Industries Ltd.
| Copaxone
| Teva Pharmaceutical Industries Ltd.
| 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 (esp. 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 two most common deficiency alleles of the alpha-1-antitrypsin gene, which is associated with development of emphysema and neonatal liver disease and cirrhosis.
|
|
