Type Action/Date

Amgen Inc.

Neupogen (FDA-approved)

Filgrastim; recombinant human granulocyte colony-stimulating factor (stimulates production of neutrophils)

Acute myelogenous leukemia (adjunct to chemotherapy)

Approved for marketing (5th indication) (4/7)

Anesta Corp. and Abbott Laboratories (NYSE:ABT)


Oral transmucosal fentanyl citrate

Break-through cancer pain in patients who are already receiving and are tolerant to opioid therapy

Approved for marketing (11/5)

Atrix Laboratories Inc. and Block Drug Corp. (NASDAQ: BLOCA)


Biodegradable polymer incorporating 10% doxycycline

Periodontal disease

Approved for marketing (9/8)

BioChem Pharma Inc. and Glaxo Wellcome plc (NYSE:GLX; U.K.)

Epivir-HBV (a.k.a. lamivudine)

Nucleoside analogue (oral dosage)

Chronic hepatitis B virus infection

Approved for marketing (12/9)

Biota Holdings Ltd. (ASX:BTA; Australia) and BioStar Inc.*


Rapid point-of-care optical immunoassay that detects influenza virus strains A and B in multiple sample types

Diagnostic test for influenza

Cleared for marketing (12/2)

Bio-Technology General Corp.


1% solution of sodium hylauronate (high molecular weight visco-elastic lubricant)

Surgical aid to protect corneal endothelium during various ophthalmic surgical procedures

Approved for marketing (7/20)

Calypte Biomedical Corp.

Urine HIV Test

Urine HIV-1 Western blot confirmatory test for antibodies to HIV-1

Assay for HIV infection

Cleared for marketing (6/1)

Celgene Corp.


Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha

Erythema nodosum leprosum, a severe condition associated with leprosy

Approved for marketing (7/16)

CellPro Inc.

Ceprate SC System (FDA-approved)

Stem cell concentration device; separates stem cells from other cells of bone marrow or peripheral blood using an avidin/biotin immuno-affinity selection system

Expanded label to include device¿s ability to concentrate stem cells from peripheral blood as a support for myelo-ablative therapy; to reduce number of tumor cells present in autograft (tumor purging)

Cleared for marketing (7/28)

Centocor Inc.

Remicade (formerly Avakine)

Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha

Moderate-to-severe Crohn¿s disease in patients for whom conventional therapy is inadequate; also for fistulizing Crohn¿s disease

Approved for marketing (8/24)

Cephalon Inc.

Provigil (modafinil)

A non-amphetamine drug for narcolepsy

To improve wakefulness in patients with excessive day time sleepiness

Approved for marketing (12/28)

Chiron Corp.

Proleukin (FDA-approved)

Recombinant human interleukin-2 (IL-2)

Single-agent therapy for metastatic melanoma in adults (stage IV)

Approved for marketing (1/12)

CollaGenex Pharmaceuticals Inc.


Orally administered drug consisting of subantibiotic dose of doxycycline (inhibits production of collagenase)

Adjunct to scaling and root planing for treating moderate-to-severe periodontitis in adults

Approved for marketing (10/1)

Cor Therapeutics Inc. and Schering-Plough Corp. (NYSE:SGP)


Eptifibatide; small-molecule compound (derived from rattlesnake venom) that inhibits GPIIb/IIIa receptor that mediates platelet aggregation

To reduce death, heart attack and other complications of percutaneous transluminal coronary angioplasty as well as in acute coronary conditions (unstable angina and non-Q-wave myocardial infarction)

Approved for marketing (5/18)

Cortecs plc (U.K.)

Link2 H. pylori Rapid Test

One-step assay for Helicobacter pylori

Diagnostic for H. pylori infection (causes peptic ulcer disease)

Cleared for marketing (6/12)

Dako A/S (Denmark)


Immunohistochemical assay; polyclonal antibody-based test to detect HER2 protein

To identify breast cancer patients whose tumors overexpress HER2 protein (for potential treatment with Herceptin)

Approved for marketing (9/25)

Diatide Inc. and Nycomed Amersham plc (U.K.)


Small-molecule synththetic peptide, designed to adhere to GPIIb/IIIa receptors on activated platelets, labeled with technetium-99m

In vivo imaging agent for acute deep vein thrombosis

Approved for marketing (9/15)

DuPont Pharmaceuticals Inc.


Efavirenz; non-nucleo-side reverse transcriptase inhibitor (once-a-day dosage)

Combination therapy with antiretroviral drugs for treating HIV infection and AIDS in adults and children

Approved for marketing (9/18)

Epitope Inc. and STC Technologies Inc.

Cocaine metabolite EIA

Enzyme immunoassay kit that detects cocaine and cocaine metabolites in oral fluids (collected with Epitope¿s OraSure oral specimen collection device)

Testing for drugs of abuse

Cleared for marketing (1/15)

G.D. Searle & Co., a division of Monsanto Co. (NYSE:MTC)


A non-steroidal antiinflammatory that selectively inhibits cyclooxygenase 2

For the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis

Approved for marketing (12/31)

GelTex Pharmaceuticals Inc. and Genzyme Corp.

RenaGel Capsules

Non-absorbed polymerbased compound that binds to and eliminates target substances from the intestinal tract

Control of elevated phosphorus levels in patients with end-stage renal disease

Approved for marketing (11/2)

Genentech Inc.


Trastuzumab; humanized monoclonal antibody to HER2 growth factor receptor

Treatment of HER2-overexpressing meta-static breast cancer; use as single agent in 2nd-and 3rd-line therapy and in combination with paclitaxel as 1st-line therapy

Approved for marketing (9/25)

Genentech Inc.

Pulmozyme (FDA-approved)

Dornase alfa; recombinant human DNase (aerosolized inhalation solution)

Reduction of incidence of respiratory tract infections in patients with cystic fibrosis

FDA approved change in label (to include patients under the age of 5) (3/2)

Genzyme Corp.


Recombinant human thyroid stimulating hormone

For use in diagnostic procedures (radio-iodine whole-body scanning) used to monitor patients for recurrence of thyroid cancer

Approved for marketing (12/1)

Glaxo Wellcome plc (NYSE:GLX; U.K.)

Ziagen (formerly 1592)

Abacavir; nucleoside analogue reverse transcriptase inhibitor (oral; tablet and liquid)

HIV infection and AIDS in children and adults (combination therapy with Epivir and Retrovir)

Approved for marketing (12/18)

Gliatech Inc.


Anti-adhesion barrier gel (semisynthetic carbohydrate polymer)

To inhibit postoperative adhesions involving spinal cord and nerve roots and to improve patient outcome following lumbar disc surgery

Approved for marketing (5/28)

Immunomedics Inc.


Immunoassay to detect human anti-mouse antibodies (HAMA) in blood

Detection and semi-quantitation of HAMA in patients receiving injections of mouse antibodies for diagnostic and/or therapeutic uses

Cleared for marketing (3/20)

Immunex Corp. and Wyeth-Ayerst Laboratories (unit of American Home Products Corp.; NYSE:AHP)


Recombinant, soluble p75 tumor necrosis factor receptor (TNFr) linked to the Fc portion of human IgG1

Moderate-to-severe active rheumatoid arthritis; for use as monotherapy in patients who have failed other therapies; also for use in combination with methotrexate

Approved for marketing (11/2)

Isis Pharmaceuticals Inc. and Ciba Vision Corp. (unit of Novartis AG; Switzerland)


Fomivirsen; antisense inhibitor of cytomegalovirus (CMV) replication (intravitreal injection)

Newly diagnosed and advanced CMV retinitis in AIDS patients

Approved for marketing (8/27)

MedImmune Inc.

CytoGam (FDA approved)

An intravenous immune globulin enriched in antibodies against cytomegalovirus (CMV)

As a prophylaxis against CMV

Approved for marketing (12/9)

MedImmune Inc.

Synagis (formerly MEDI 493)

Palivizumab; humanized monoclonal antibody to respiratory syncytial virus (RSV); binds to fusion protein on viral surface (intramuscular injection)

Prevention of serious RSV disease in certain high-risk infants and young children (causes pneumonia, bronchiolitis)

Approved for marketing (6/19)

Metra Biosystems Inc.


Serum-based test that measures bone-specific alkaline phosphatase levels (marker for bone formation)

Assay to monitor effects of drugs used for treating or preventing osteoporosis

Cleared for marketing (6/8)

Metra Biosystems Inc.

Pyrilinks-D Assay (FDA-approved)

Urine-based assay that measures excretion of deoxypyridinoline cross links (immunoassay; biochemical indicator of bone resorption)

Test to monitor antiresorptive drugs (including Fosamax) in treatment and prevention of post-menopausal osteoporosis women

Cleared for marketing (2/3); Label expanded to include monitoring patient response to hormone replacement therapy (8/17)

Merck & Co. Inc. (NYSE:MRK)


Tirofiban HCl; non-peptide inhibitor of platelet aggregation based on peptide in venom of saw-scaled viper snake; blocks GPIIb/IIIa platelet receptor (intravenous)

Treatment of acute coronary syndromes (unstable angina and non-Q-wave myocardial infarction) in patients who need drug therapy only, as well as in those who are expected to undergo angioplasty

Approved for marketing (5/14)

Merck & Co. Inc. (NYSE:MRK)


Indinavir sulfate; HIV protease inhibitor

Treatment of HIV infection, either as monotherapy or in combination with nucleoside analogues

Received traditional marketing approval (initially approved under accelerated review 3/96) (3/5)

MGI Pharma Inc.

Salagen Tablets

Pilocarpine HCl

Treatment of dry mouth caused by Sjogren¿s syndrome (autoimmune disease)

Approved for marketing (2/17)

North American Vaccine Inc.


Combined diphtheria, tetanus and acellular pertussis (DTaP; detoxified pertussis toxin) vaccine

Active immunization in infants and children 6 weeks to 7 years of age against diphtheria, tetanus and pertussis (whooping cough)

Approved for marketing (7/30)

Novartis Pharmaceuticals Corp. (unit of Novartis AG; Switzerland)


Basiliximab; selective high-affinity monoclonal antibody that blocks receptor for interleukin-2

Prevention of acute rejection episodes after kidney transplantation

Approved for marketing (5/13)

Noven Pharmaceuticals Inc.


Transdermal patch containing estradiol and norethindone acetate (estrogen/progestogen)

Relief of moderate-to-severe vasomotor symptoms in menopausal women (hormone replacement therapy)

Approved for marketing (8/10)

Organogenesis Inc. and Novartis Pharma AG (Switzerland)

Apligraf (a.k.a. Graftskin)

Living human skin equivalent, composed of living human keratinocytes and fibroblasts (epidermis and dermis; isolated from infant foreskins) cultured in a 3-dimensional system

Treatment of venous leg ulcers (of greater than 1 month¿s duration)

Approved for marketing (5/26)

Ostex International Inc.

Osteomark Assay (FDA-approved)

Assay that measures cross-linked N-telopeptides of type I collagen excreted in urine

To determine probability of reduction in bone mineral density in postmenopausal women not taking hormonal anti-resorptive therapy

FDA approved expanded indication (3/26)

Penederm Inc.

Avita Gel

Topical formulation of retinoic acid (tretinoin); employs TopiCare liquid polymers for drug delivery

Treatment of acne

Cleared for marketing (2/3)

Pharmos Corp. and Bausch & Lomb Pharmaceuticals Inc. (NYSE:BOL)


Loteprednol etabonate ophthalmic suspension 0.2% (topical steroid)

Treatment of ophthalmic allergies (especially seasonal allergic conjunctivitis)

Approved for marketing (3/10)

Pharmos Corp. and Bausch & Lomb Pharmaceuticals Inc. (NYSE:BOL)


Loteprednol etabonate ophthalmic suspension 0.5% (topical steroid)

Treatment of ophthalmic inflammation (especially post-operative)

Approved for marketing (3/10)

ProCyte Corp.

OsmoCyte PCA Pillow Wound Dressing

Hydropolymer dressing containing copper peptide gel

Wound dressing for acute and chronic wounds

Cleared for marketing (4/7)

QLT PhotoTherapeutics Inc. (Canada) and Sanofi Pharmaceuticals Inc. (unit of Sanofi SA; France)

Photofrin (FDA-approved)

Photosensitive drug (produces toxic oxygen compound when light-activated)

Treatment of micro-invasive endobronchial non-small-cell lung cancer (early-stage) in patients who are not indicated for surgery and radiotherapy

Label expanded (1/9)

QLT PhotoTherapeutics Inc. (Canada) and Sanofi Pharmaceuticals Inc. (unit of Sanofi SA; France)

Photofrin (FDA-approved)

Photosensitive drug (produces toxic oxygen compound when light-activated)

For the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small cell cancer (late-stage)

Label expanded (12/23)

Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc SA; NYSE:RP; France)

Taxotere (FDA-approved)

Docetaxel; semisynthetic agent derived from needles of the European yew tree; inhibits cancer cell division by preventing assembly and blocking disassembly of microtubules

Metastatic breast cancer in patients who have failed any previous chemotherapy

Approved for marketing (6/23)

SangStat Medical Corp.

SangCya (formerly Sang-35)

Cyclosporine (oral formulation bioequivalent to Neoral oral solution)

Prevention of rejection in solid organ transplant recipients

Cleared for marketing (11/3)

SangStat Medical Corp. and the Imtix division of Pasteur Merieux Connaught (member of the Rhone-Poulenc Group; France)


Rabbit anti-human thymocyte polyclonal antibody

Treatment and prevention of acute graft rejection episodes in kidney transplant patients

FDA sent companies a ¿complete review¿ letter regarding the PLA (1/28)

Schering-Plough Corp. (NYSE:SGP)

Intron A (FDA-approved)

Recombinant human interferon alfa-2b; injection

Chronic hepatitis B virus infection in children 1 year or older

Approved for marketing (8/25)

Schering-Plough Corp. (NYSE:SGP) and ICN Pharmaceuticals Inc. (NYSE:ICN)


Combination of Intron A (recombinant human interferon alfa-2b; injection) and Rebetol (ribavirin; synthetic nucleoside with antiviral activity; oral) (each product separately approved by FDA for other uses)

Combination therapy for treating chronic hepatitis C virus infection in patients with compensated liver disease who have relapsed following alpha-interferon therapy

Approved for marketing (6/3); label expanded to include use as first line therapy (12/9)

SmithKline Beecham plc (NYSE:SBH; U.K.)

Engerix-B (FDA-approved)

Recombinant hepatitis B vaccine

Prevention of hepatitis B virus infection in patients with chronic hepatitis C virus infection

Approved for marketing (8/13)

SmithKline Beecham plc (NYSE:SBH; U.K.)


Recombinant OspA vaccine (outer surface protein A; antigen from tick-borne bacterium Borrelia burgdorferi, which causes the infection)

Prevention of Lyme disease (both definitive disease and asymptomatic infection)

Approved for marketing (12/21)

SuperGen Inc.


Mitomycin for injection

Combination therapy with approved chemotherapeutic drugs for treating adenocarcinoma of the stomach and pancreas

Approved for marketing (5/4)

Vysis Inc.

PathVysion HER2 DNA Probe Kit

Assay based on fluorescent in situ hybridization technology; uses locus-specific, direct-label DNA probe that binds to HER2 gene in tissue biopsy

To detect and quantify HER2 gene in patients with breast cancer

Approved for marketing (12/14)