Abbott Laboratories


Enzyme-linked immunosorbant assay

Blood test for HTLV-1 and HTLV-II (8/18)

Abbott Laboratories

Norvir (FDA- approved)

Ritonavir; HIV protease inhibitor

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.


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.


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)


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)


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.)


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


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.


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.


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.


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.)


Chemiluminescent immunoassay system

Automated diagnostic system (8/7)

Chiron Corp.


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.


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.


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.


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.)


Recombinant human coagulation Factor IX

Hemophilia B (2/12)

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


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

Amplified nucleic acid acid probe

Tuberculosis test (6/18)

Gensia Labor- atories Ltd. (wholly owned subsidiary of Gensia Sicor Inc.)

Desmopressin Acetate Injection

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.)


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.


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.


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.


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.


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


Liposomal formulation of amphotericin B

Empirical therapy for presumed fungal infections in patients with depressed immune function and fever of unknown origin (8/12)

Organogenesis Inc.


Porcine-source, non-living connective tissue patch

For use in general surgical procedures for reinforcement of soft tissue (8/8)

Organon Inc. affiliate of Organon NV; the Netherlands)


Follitropin-beta; recom- binant human follicle- stimulating hormone

Treatment of infertility (through assisted repro- ductive technology program) (subcutaneous injection) (9/29)

PathoGenesis Corp.


Tobramycin for inhalation

Chronic lung infections (Pseudomonas aerugi- nosa) in patients with cystic fibrosis (12/22)

Penederm Inc.

Avita Cream

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

Treatment of acne (1/16)

Penederm Inc.


Butenafine HCL, 1 ream (benzylamine, antifungal agent; topical)

Tinea corporis (ringworm) and tinea cruris (groin fungus) (expanded label) (1/3)

Pharmacia & Upjohn Inc.


Recombinant human growth hormone

Long-term replacement therapy in adults with growth hormone deficiency (expanded label) (11/7)

Pharmacia & Upjohn Inc.


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.;


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)


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.


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

Diagnosis and monitoring of periodontitis (6/24)