Indication (U.S. Approval Date)

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; 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.


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.


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. (Japan)

Consensus alpha interferon for hepatitis C (10/97)

Athena Neurosciences Inc. (subsidiary of Elan Corp plc; Ireland)


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.


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.


Biogen Inc.

Multiple sclerosis (5/96)

Biogen Inc.


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.


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.


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.


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)


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.


Eli Lilly and Co.

To inhibit platelet aggregation in high-risk angioplasty (12/94)

Centocor Inc.


Centocor Inc.

Crohn¿s disease (8/98)

ChemTrak Inc.

Hp Chek

Astra Merck

Point-of-care diagnostic assay for Helicobacter pylori (7/96)

Chiron Corp.


Berlex Laboratories Inc.

Relapsing, remitting multiple sclerosis (7/93)

Chiron Corp.


Chiron Corp.

Renal cell carcinoma (5/92); metastatic melanoma (1/98)

Chiron Diagnostics (former business unit of Chiron Corp; division acquired by Bayer AG in 1998)


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)


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)


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 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.


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.


Cygnus Inc.

Smoking cessation (7/96)

Cytogen Corp.


CIB bio-International CR/OV

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)

Diatide Inc.


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)


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)


Eli Lilly and Co.

Diabetes (6/96)

Eli Lilly and Co. (NYSE:LLY)


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)

GelTex Pharmaceuticals Inc.


Genzyme General

Reduction of serum phosphorus in patients with end-stage renal disease (11/98)

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 40% lung function) (12/96); treatment of cystic fibrosis in infants and young children (3/98)

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.


Genentech Inc.

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

Genentech Inc.


Eli Lilly and Co. (NYSE:LLY)

Diabetes (10/82)

Genentech Inc.


Genentech Inc.

Chronic granulomatous disease (12/90)

Genentech Inc.


Genentech Inc.

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.


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)


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)


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.


Genzyme Corp.

Type I Gaucher¿s disease (4/91)

Genzyme Corp.


Genzyme Corp.

Type I Gaucher¿s disease (5/94)

Genzyme Corp.


Genzyme Corp.

To reduce postsurgical adhesions following open abdominal or pelvic surgery (8/96)

Genzyme Corp.


Genzyme Corp.

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

Genzyme Corp.


Knoll Pharmaceutical Co.

Follow-up diagnostic for patients who have been treated for thyroid cancer (12/98)

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 interferon 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 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.


Immunex Corp.

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

Immunex Corp.


Wyeth-Ayerst Laboratories

Rheumatoid arthritis (10/98)

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 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.


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.


CIBA Vision Corp.

Treatment of cytomegalovirus retinitis in AIDS patients (8/98)

Ligand Pharmaceuticals Inc.


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.


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.


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.


MedImmune/Abbott Laboratories

Prevention of respiratory syncytial virus in children and infants (6/98)

Merck & Co. Inc. (NYSE:MRK)


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)


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.


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.


Swedish Orphan AB

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

North American Vaccine


Abbott Laboratories Inc.

Combined diphtheria, tetanus and acellular pertussis vaccine (8/98)

Novo Nordisk A/S (Denmark)


Novo Nordisk A/S

Insulin-dependent diabetes mellitus (7/91)

Novo Nordisk A/S (Denmark)


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.


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)


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.



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 Phototherapeutics 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

Hoffmann-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.

Invasive aspergillosis infections (2nd-line therapy) (11/96)

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


Serono Laboratories Inc.

Growth hormone deficiency in children (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)

SmithKline Beecham plc


SmithKline Beecham plc

Lyme disease

Teva Pharmaceutical Industries Ltd. (Israel)


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 (especially 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 2 most common deficiency alleles of the alpha-1-antitrypsin gene, which is associated with development of emphysema and neonatal liver disease and cirrhosis