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.*
AB FLU OIA
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.
BioLon
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.
Thalomid
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.
Periostat
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)
Integrilin
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)
HercepTest
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.)
AcuTect
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
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)
Celebrex
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.
Herceptin
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.
Thyrogen
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.
Adcon-L
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.
ImmuSTRIP-HAMA
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)
Enbrel
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)
Vitravene
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.
Alkphase-B
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)
Aggrastat
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)
Crixivan
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)
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)
Simulect
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.
CombiPatch
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)
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)
Thymo-globulin
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)
Rebetron
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.)
LYMErix
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
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
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