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.


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