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


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.


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.


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.


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.


Amgen Inc; Yamanouchi Pharmaceutical Co. Ltd.

Consensus alpha interferon for hepatitis C (10/97)




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.


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.


Biogen Inc.

Multiple sclerosis (5/96)

Biogen Inc.


SmithKline Beechman plc

Hepatitis B vaccine (9/89)

Biogen Inc.

Recombivax HB

Merck & Co. Inc.

Hepatitis B vaccine (7/86)

Biogen Inc.


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.


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.


Biomira Inc.; Immunex Corp.

Diagnostic test for recurrence of breast cancer in women previously treated for stage II/III disease (4/96)

Biora AB


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.


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)


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)


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.


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.)


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)


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.)


Chiron Corp.

Cytomegalovirus retinitis infection in AIDS patients (3/96)

Connaught Laboratories Inc.


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.


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.


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.


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)


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.


Eli Lilly and Co.

Diabetes (6/96)

Eli Lilly and Co.


Eli Lilly and Co.

Human growth hormone deficiency in children (3/87); somatotropin deficiency syndrome in adults (8/96)

Enzon Inc.


Enzon Inc.

Treatment of infants and children with severe combined immunodeficiency (1990)

Enzon Inc.


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. .


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.


Genentech Inc.

Cystic fibrosis (12/93); treatment of cystic fibrosis in severely ill patients (less than 400ng function) (12/96)

Genentech Inc.


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.


Genetech Inc.

Growth hormone inadequacy; growth failure associated with chronic renalinsufficiency (10/85)

Genentech Inc.


Eli Lilly and Co.

Diabetes (10/82)

Genentech Inc.


Genetech Inc.

Chronic granulomatous disease (12/90)

Genentech Inc.


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.)


Baxter International Inc.

Blood clotting factor VIII for hemophilia A

Genetics Institute Inc. (subsidiary of American Home Products Corp.)


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.


Genzyme Corp.

Type I Gaucher's disease (1991)

Genzyme Corp.


Genzyme Corp.

Type I Gaucher's disease (5/94)

Genzyme Corp.


Genzyme Corp.

To reduce post-surgical adhesions following open abdominal or pelvic surgery (8/96)

Genzyme Corp.


Genzyme Corp.

Autologous cultured chondrocytes to repair knee cartilage damage (8/97)

Gilead Sciences Inc.


Pharmacia & Upjohn Inc; U.K.

To delay progression of cytomegalovirus retinitis in AIDS patients (6/96)

Guilford Pharmaceuticals Inc.


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)


Recombinant inter- feron alpha-2A

Chronic hepatitis C virus infection (11/96)

Hoffmann- La Roche Inc. (unit of Roche Holding Ltd; Switzerland)


T-type calcium channel blocker (6/97)

Hemagen Diagnostics Inc.


Elisa test to detect antibodies against human DNA

Diagnosis of lupus (12/96)

Idec Pharmaceuticals Corp.


Idec Pharmaceuticals Corp.

Monoclonal antibody for low-grade non-Hodgkin's lymphoma recurrences (11/97)


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.


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.


Immunex Corp.

Treatment of hormone refractory prostate cancer (in combination with steroids) (11/96)

Immunomedics Inc.


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.


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.


Connaught Laboratories Inc.

Prevention of cytomegalovirus in kidney transplant patients (11/91)

MedImmune Inc.


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.


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.)


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.


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.


Swedish Orphan AB

1st line therapy for Kaposi's sarcoma in AIDS patients (4/96)

Novo Nordisk A/S


Novo Nordisk A/S

Insulin-dependent diabetes mellitus (7/91)

Novo Nordisk A/S


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.



Periodontal tissue monitor kit

Penederm Inc.


Penederm Inc.

Interdigital tinea pedis (athlete's foot) (10/96)

Pharmacia & Upjohn Inc.


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.


Sanofi Winthrop Inc.

Advanced throat cancer (12/95)

Quidel Corp.


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)


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)


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.


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)


Serono Laboratories Inc.

Treatment of children with growth hormone deficiency (10/96)

Serono Laboratories Inc. (business unit of Ares-Serono Group; Switzerland)


Serono Laboratories Inc.

AIDS wasting (cachexia) in adults (8/96)

Serono Laboratories Inc. (business unit of Ares-Serono Group; Switzerland)


Serono Laboratories Inc.

Infertility treatment (8/96) hormone deficiency (10/96)

Teva Pharmaceutical Industries Ltd.


Teva Pharmaceutical Industries Ltd.

To reduce flare-ups in relapsing multiple sclerosis (12/96)

The Liposome Co. Inc.


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.


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.


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.


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.