Treatment of HIV infection and AIDS in children (for use alone or in combination with nucleoside analogues) (expanded label) (3/14)
AccuMed International Inc.
ESP Culture System II
Nucleic acid probes
Tuberculosis test for additional use in ident- ification of the mycobacteria present (8/25)
Adeza Biomedical Corp.
Fetal Fibronectin Test
Immunoassay that detects presence of fetal fibronectin in vaginal secretions
Test to detect risk of pre-term delivery, ex- panded to include use in women without symp- toms of pre-term labor (1/13)
Advanced Polymer Systems Inc. and Ortho Dermatologic (unit of Johnson & Johnson)
Retin-A Micro
Tretinoin gel micro- sphere, 0.1% (topical); uses polymer-based MicroSponge delivery system
Treatment of acne (2/10)
Advanced Tissue Sciences Inc. and Smith & Nephew plc (U.K.)
Dermagraft- TC
Engineered human dermal tissue combined with synthetic epidermal layer
Temporary covering for serious burns (full thickness and deep partial thickness burns) (3/18); indication expanded to include partial thickness burns (10/20)
Agouron Pharmaceuticals Inc.
Viracept (formerly protease AG1343)
Synthetic small molecule designed to inhibit HIV
HIV infection in adults and children (for use alone or in combination with nucleo- side analogues) (3/14)
Allergan Inc.
Tazorac (tazarotene topical gel)
Receptor-selective retinoid
Stable plaque psoriasis and facial acne (6/23)
Alza Corp.
Testoderm
Testosterone transdermal patch
For treatment of testosterone deficiency (12/22) delivers 5mg dose of testosterone through skin of arm, back or buttocks
American Biogenetic Sciences Inc.
Functional Intact Fibrino- gen test
Measuring the quantity of fibrinogen in human plasma
To measure levels of clottable protein in blood (6/18)
Amgen Inc.
Infergen
Concensus alpha interferon; non-natural recombinant type 1 alpha interferon
Chronic hepatitis C virus infection (10/7)
Athena Neuro- sciences Inc. (wholly owned . Subsidiary of Elan Corp plc; Ireland)
Carbatrol
Carbamazepine extended-release capsules
Anticonvulsant for use in patients with epilepsy; also for treating pain associated with trigeminal neuralgia (10/2)
Athena Neurosciences Inc. (wholly owned Subsidiary of Elan Corp. plc.; Ireland)
Diastat
Diazepam rectal gel (designed for home use)
Treatment of acute repetitive seizures in patients with severe epilepsy (7/31)
BioChem Pharma Inc. (Canada) and Glaxo Wellcome plc (U.K.)
Combivir
Combination of anti- retroviral drugs 3TC/ Epivir (Lamivudine)and AZT (Retrovir) in single tablet
HIV infection and AIDS (9/29)
BioChem Pharma Inc. and Glaxo Wellcome plc
Epivir
3TC; nucleoside analogue
To reduce risk of death and disease progression in HIV infection and AIDS (combination therapy with AZT) (Accelerated approval 11/95; full marketing approval 4/14)
Biomatrix Inc.
Synvisc
Elastoviscous hylan bio- polymer; chemically modified version of natural hyaluronan
Osteoarthritis of the knee(8/13)
Biomira Inc. (Canada)
Truquant BR
Radioimmunoassay that incorporates B27.29 antibody (detects CA 27.29 breast tumor antigen in blood)
To monitor response to therapy in patients with stage IV breast cancer (supplemental use) (11/6)
Biosite Diagnostics Inc.
Triage Cardiac Panel
Point-of-care immunodiagnostic; measures levels of creatinine kinase, myoglobin and troponin I in blood
Diagnostic for acute myocardial infarction (when used with Triage Meter) (10/13)
Bristol-Myers Squibb Co.
Taxol
Semisynthetic taxane; inhibits cancer cell division by blocking microtubule assembly/ disassembly; derived from needles and twigs of of yew tree
2nd-line treatment for AIDS-related Kaposi's sarcoma (expanded indication) (8/5)
Centocor Inc. and Fisher Scientific
CA 15-3 RIA
Serum tumor marker radio immunoassay
Monitoring patients with breast cancer (6/16)
Centocor Inc. and Eli Lilly and Co.
ReoPro
Chimeric monoclonal antibody fragment to GPIIb/IIIa platelet receptor
Adjunctive therapy to be used 18-24 hours prior to any percutaneous coronary intervention (to prevent cardiac ischemic complications in broad range of patients, including those with unstable angina not responding to normal therapy) (expanded label) (11/6)
ChemTrak Inc.
Accumeter Theophylline Test
Point-of-care quantitative assay for bron- chodilator theophylline in whole blood
Use in frequent monitoring of drug use by patients with acute and chronic asthma; to insure optimal dosing and reduce incidence of serious side effects (10/30)
Chiron Diagnostics (unit of Chiron Corp.)
ACS:180 BR
In vitro test for the quanti- tative serial determination of CA 27.29, a glycoprotein associated with metastatic breast cancer
Monitoring test for metastatic breast cancer (8/14)
Chiron Diagnostics (unit of Chiron Corp.)
ACS:Centaur
Chemiluminescent immunoassay system
Automated diagnostic system (8/7)
Chiron Corp.
RabAvert
Rabies vaccine, manufactured by process that removes most of human albumin
Use in pre-exposure vaccination and post- exposure prophylaxis against rabies in humans (11/3)
Chiron Corp. and Johnson & Johnson
Regranex (becaplermin)
Gel form of recombinant human platelet-derived growth factor beta
Diabetic foot ulcers (12/17)
Columbia Laboratories Inc.
Crinone
Vaginally delivered natural progesterone gel
For use in advanced reproductive technol- ogies (including in vitro fertilization) (Cleared 5/14; Indication expanded to include secondary amenorrhea, 8/1)
Cytogen Corp.
Quadramet
Samarium 153-EDTMP (complex of radioactive samarium and a tetra- phosphonate chelator EDTMP)
Treatment of severe pain associated with cancers that have spread to bone (3/31)
Eli Lilly and Co.
Humatrope
Recombinant human growth hormone
Treatment of short stature associated with Turner's syndrome (expanded indication 4/1)
Genetics Institute Inc. (wholly owned subsidiary of American Home Products Corp.)
BeneFix
Recombinant human coagulation Factor IX
Hemophilia B (2/12)
Genetics Institute Inc. (wholly owned subsidiary of American Home Products Corp.)
Neumega
Oprelvekin; human recombinant interleukin-11; platelet growth factor
Prevention of recurrent, severe, chemotherapy- induced thrombocytopenia in cancer patients (11/25)
Genentech Inc.
Nutropin AQ
Recombinant human growth hormone (aqueous formulation)
Long-term treatment of short stature associated with Turner's syndrome (expanded indication 4/1)
Gen Probe Inc.
Gen-Probe Amplified My- cobacterium Tuberculosis Direct Test
Synthetic version of antidiuretic hormone vasopressin
To maintain hemostasis and control bleeding during surgery or as a result of injury to pit- uitary gland; also, treatment of patients with hemophilia A or von Willebrand¿s disease (10/20)
Gensia Sicor Inc.
GenESA System
System that combines drug arbutamine with computer controlled drug administration system
For diagnosing coronary artery disease in conjunction with radionuclide myocardial perfusion imaging in patients who cannot exercise adequately (stress test) (9/12)
Genzyme Tissue Repair (unit of Genzyme Corp.)
Carticel
Cartilage cell culturing service; sample taken from patient's own knee is used to grow replace- ment cartilage, which is then reimplanted
Cartilage replacement in patients with damage to articular cartilage in the knee (8/25)
Genzyme Corp.
N-Geneous LDL; N-Geneous HDL
2nd-generation homo- geneous direct high- and low-density lipoprotein assays (measure choles- terol levels in serum or plasma)
LDL and HDL cholesterol tests (9/10)
Hemagen Diagnostics Inc.
VIRGO ELISA CMV IgG Kit
Enzyme-linked immuno- assay that detects and measures antibodies to cytomegalovirus (CMV) in serum
To detect current or past CMV infection (2/27)
Hemagen Diagnostics Inc.
Quantitative, latex-enhanced agglutination assay that measures rheumatoid factor (RF) in serum
Diagnostic assay for rheumatoid arthritis (4/29)
Hemagen Diagnostics Inc.
Virgo Anti- Cardiolipin test kit
ELISA test that screens ser- um for autoantibodies relat- ed to systemic lupus erythe- matosus and other autoim- mune diseases
Diagnosis of autoimmune diseases (6/11)
Hemagen Diagnostics Inc.
Virgo Anti- mitochondrial Antibody Kit
Test for mitochondrial antibody
Screen for primary biliary cirrhosis (6/25)
Hemagen Diagnostics Inc.
Virgo ANCA, pANCA, cANCA Screen
Test for anti-neutrophil cytoplasmic antibodies
Screen for Wegener's disease; a systemic vasculitis characterized by lesions in the upper and lower respiratory tract and kidney (12/5)
Hoffmann-La Roche Inc. (subsidiary of Roche Holding Ltd.; Switzerland)
Fortovase (Saquinivir)
Saquinivir (invirase); HIV protease inhibitor in soft gelatin capsule (new, more potent form- ulation)
Combination therapy with antiretroviral agents for treating HIV infection and AIDS (11/7)
Idec Pharma- ceuticals Corp. and Genentech Inc.
Rituxan
Rituximab; genetically engineered chimeric pan-B monoclonal anti- body that targets CD20 antigen on B-cell surface
Relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma (single-agent therapy) (11/26)
Immucor Inc.
Capture-S
Assay that detects anti- lipid antibodies in plas- ma or serum
Syphilis screening test (for blood banks and plasma collection centers) (11/4)
Immunex Corp.
Novantrone (mitoxan trone)
Synthetic anthracene- dinone
Prostate cancer (in combination with corticosteroids); expanded label reflects drug's ability to reduce prostate specific antigen levels (6/12)
Integra LifeSciences Corp.
Integra Artificial Skin
Product consists of bovine tendon derived implantable matrix with an outer layer of a silicone-based sub- stitute for epidermis
Wound healing in full-thickness burns; product granted 24-month shelf life (8/8)
Merck & Co. Inc.
Fosamax
Alendronate sulfate
Prevention of osteoporosis in post-menopausal women; also prevention of bone fracture in post- menopausal women with osteoporosis (4/28)
Neurex Corp.
Corlopam (fenoldo- pam)
Dopamine receptor agonist that causes dilation of blood vessels
Severe high blood pressure; short-term hypertension when oral therapy cannot be used throughout the body (9/24)
NeXstar Pharma- ceuticals Inc. and Fujisawa USA
AmBisome
Liposomal formulation of amphotericin B
Empirical therapy for presumed fungal infections in patients with depressed immune function and fever of unknown origin (8/12)
Tinea corporis (ringworm) and tinea cruris (groin fungus) (expanded label) (1/3)
Pharmacia & Upjohn Inc.
Genotropin
Recombinant human growth hormone
Long-term replacement therapy in adults with growth hormone deficiency (expanded label) (11/7)
Pharmacia & Upjohn Inc.
Rescriptor
Delavirdine; non-nucleo- side analogue reverse transcriptase inhibitor
HIV infection (combination therapy with other antivirals, including AZT, ddI, ddC, 3TC and d4T) (accelerated approval 4/7)
ProCyte Corp.
GraftCyte Moist Dressing
Gauze wound dressing that contains copper peptide compound in a gel
For use in hair restoration procedures to pro- mote natural wound healing (3/14)
Protein Design Labs Inc. and Hoffmann-La Roche Inc. (unit 0f Roche Holding Ltd.;
Zenapax
Dacliximab; humanized monoclonal antibody (SMART AntiTac) that binds to the interleukin-2 receptor on activated T cells
Prevention of organ rejection following kidney transplantation (12/11)
Schering-Plough Corp.
Intron A
Recombinant human interferon alfa-2b
Chronic hepatitis C infection; FDA approved extended dosing regimen (18-24 months) (3/26)
Schering-Plough Corp.
Intron A
Recombinant human interferon alfa-2b
Initial treatment of non-Hodgkin's lymphoma in combination with anthracycline therapy (new indication) (11/10)
Serono Laborat- ories Inc. (member of The Ares- Serono Group; Switzerland)
Geref
Sermorelin acetate; amidated synthetic 29 amino acid peptide that corresponds to amino terminal of natural human growth hormone releasing hormone
Growth hormone deficiency in children with growth failure (10/3)
Serono Laboratories Inc.
Gonal-F
Recombinant human follicle-stimulating hormone
Treatment of infertility through assisted repro- ductive technology program (subcutaneous injection) (9/30)
TAP Holdings Inc. (joint venture of Abbott Laborator- ies; and Takeda Chemical Industries; Japan)
Lupron Depot
Luprolide acetate for depot suspension; gonadotropin releasing hormone analogue that inhibits testosterone production
Palliative treatment of advanced prostate cancer (7/18)
Trinity Biotech plc. (Ireland)
Rotavirus Test Kit
Enzyme immunoassay (EIA)
Diarrhea in children (9/4) that rapidly detects presence of rotavirus in stool samples
United Biomedical Inc.
Diagnostic test that detects antibodies to viruses; based on synthetic peptides
Assay for AIDS viruses HIV-1 and HIV-2 (for use in diagnostic labs and donor screening) (1/3)
Vysis Inc.
AneuVysion Assay
Assay that uses fluorescence in situ hybridization (FISH) technology to measure aneu- ploid nuclei in amniocentesis specimens; 24-hour turn- around time
Prenatal genetic test for Down syndrome and other chromosomal disorders associated with mental retardation and birth defects (10/28)
Xytronyx Inc. and Steri-Oss Inc.
Periodontal Tissue Monitor Kit
Detects elevated levels of aspartate aminotransferase associated with tissue necrosis
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