Table of Contents
FDA Consumer magazine
May-June 2000
By Tamar Nordenberg
A new device that can improve blood flow to the heart by puncturing tiny therapeutic holes in places that traditional coronary artery bypass surgery can't reach is just one of more than 140 medical products approved by FDA last year.
In 1999, FDA approved a wide range of innovative health care products to treat medical conditions both common and rare--from brain and breast cancer, HIV, heart disease, and diabetes to the little-known but potentially life-threatening genetic disorder called familial adenomatous polyposis.
The agency's Center for Drug Evaluation and Research approved 83 new drugs in a median FDA review time of just under 12 months overall and a little over six months for the 28 "priority" products deemed to represent a significant advance over existing treatment options. The Center for Biologics Evaluation and Research approved 24 products in a median time of just under 8.5 months. And the Center for Devices and Radiological Health approved 41 products in about a nin-month median total review time.
Among the drugs and devices approved were 20 drugs and biologics that qualify under the Orphan Drug program, which grants special privileges and marketing incentives to makers of treatments for conditions affecting fewer than 200,000 patients, too few to be routinely profitable.
In addition, seven products were developed under the Humanitarian Device Exemption, which exempts manufacturers from conducting clinical trials in some cases in which a device's benefit is expected to a reach a U.S. patient population of fewer than 4,000.
The following chart lists some of the most important drugs and devices that FDA has OK'd for marketing in 1999 some for the first time and others for a new use along with a general description of the condition for which each is newly approved.
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DRUGS (INCLUDING BIOLOGICS) |
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Product Name |
Use |
Sponsor |
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Rare Diseases |
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Ontak (denileukin diftitox) |
cutaneous t-cell lymphoma |
Seragen Inc. (Hopkinton, Mass.) |
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Targretin (bexarotene) |
cutaneous t-cell lymphoma |
Ligand Pharmaceuticals Inc. (San Diego) |
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Ellence (epirubicin hydrochloride) |
breast cancer |
Pharmacia and Upjohn Co. (Bridgewater,N.J.) |
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Temodar (temozolomide) |
brain cancer |
Schering Corp. (Kenilworth, N.J.) |
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Humate-P (antihemophilic factor/von Willebrand factor complex) |
von Willebrand's disease |
Centeon Pharma G.m.b.H. (Germany) |
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NovoSeven (recombinant coagulation factor VIIa) |
hemophilia A or B |
Novo Nordisk A/S (Denmark) |
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Nutropin Depot (somatropin) |
growth failure |
Genentech Inc. (San Francisco) |
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Enbrel (etanercept) |
juvenile rheumatoid arthritis |
Immunex Corp. (Seattle) |
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Cafcit (caffeine citrate) |
pediatric breathing interruptions |
Roxane Laboratories (Columbus, Ohio) |
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Curosurf (poractant alfa) |
pediatric respiratory distress syndrome |
Dey, L.P. (Napa, Calif.) |
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INOmax (nitric oxide) |
infant respiratory failure |
INO Therapeutics Inc. (Clinton, N.J.) |
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Cancer |
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Aromasin (exemestane) |
advanced breast cancer |
Pharmacia and Upjohn Co. (Bridgewater, N.J.) |
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Taxotere (docetaxel) |
non-small cell lung cancer |
Rhône-Poulenc Rorer Pharmaceuticals Inc.(Collegeville, Pa.) |
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Celebrex (celecoxib) |
familial adenomatous polyposis |
Searle (Skokie, Ill.) |
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HIV and AIDS |
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Agenerase (amprenavir) |
HIV (protease inhibitor) |
Glaxo Wellcome Inc. (Research Triangle Park, N.C.) |
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Panretin (alitretinoin) |
AIDS-related lesions |
Ligand Pharmaceuticals Inc. (San Diego) |
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Videx Chewable Tablets and Oral Solution |
HIV |
Bristol-Myers Squibb Co. (Princeton, N.J.) |
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(didanosine) (new strength) |
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Conditions Affecting the Elderly |
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Vioxx (rofecoxib) |
rheumatoid and osteoarthritis, menstrual pain, acute pain in adults |
Merck & Company Inc. (Whitehouse Station, N.J.) |
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Remicade (infliximab) |
rheumatoid arthritis |
Centocor Inc. (Malvern, Pa.) |
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Aggrenox (aspirin and dipyridamole) |
stroke risk reduction |
Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, Conn.) |
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Diabetes |
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Actos (pioglitazone hydrochloride) |
Type II (adult-onset) diabetes |
Takeda America Research & Development Center Inc. (Princeton, N.J.) |
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Avandia (rosiglitazone) |
Type II (adult-onset) diabetes |
SmithKline Beecham Pharmaceuticals (Philadelphia) |
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Hepatitis |
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Infergen (interferon alfacon-1) |
hepatitis C |
Amgen Inc. (Thousand Oaks, Calif.) |
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Roferon-A (interferon alfa-2a) |
hepatitis C (new dosing regimen) |
Hoffmann-La Roche Inc. (Nutley, N.J.) |
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Recombivax |
hepatitis B vaccine (without preservative) |
Merck & Company Inc. (Whitehouse Station, N.J.) |
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Psychological Conditions |
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Paxil (paroxetine hydrochloride) |
social phobia |
SmithKline Beecham Pharmaceuticals (Philadelphia) |
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Zoloft (sertraline hydrochloride) |
post-traumatic stress disorder |
Pfizer Inc. (New York) |
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Infectious Diseases |
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Synercid |
vancomycin-resistant Enterococcus faecium and complicated skin infections |
Rhône-Poulenc Rorer Pharmaceuticals Inc. Collegeville, Pa.) |
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Relenza (zanamivir) |
flu |
Glaxo Wellcome Inc. (Research Triangle Park, N.C.) |
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Tamiflu (oseltamivir phosphate) |
flu |
Roche Pharmaceuticals (Puerto Rico) |
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Pediatric Conditions |
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Immune Globulin Intravenous |
Kawasaki syndrome |
Baxter Healthcare Corp. (Glendale, Calif.) |
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Other Conditions |
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Rapamune (sirolimus) |
prevent acute rejection of transplanted kidneys |
Wyeth-Ayerst Laboratories (Philadelphia) |
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Keppra (levetiracetam) |
control partial onset epileptic seizures |
UCB Pharma Inc. (Smyrna, Ga.) |
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Xenical (orlistat) |
obesity |
Roche Pharmaceuticals (Puerto Rico) |
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MEDICAL DEVICES |
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Rare Diseases |
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Shelhigh Pulmonic Valve Conduit NR-4000 |
replaces damaged cardiac arteries in children |
Shelhigh Inc. (Millburn, N.J.) |
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Cardioseal Septal Occlusion System |
closes holes between heart's left and right sides |
Nitinol Medical Technologies Inc. (Boston) |
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Cancer |
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T-Scan 2000 |
breast cancer diagnosis |
TransScan Medical Inc. (Ramsey, N.J.) |
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Levulan Kerastick |
precancerous skin lesions |
DUSA Pharmaceuticals Inc. (Valhalla, N.Y.) |
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Isolex 300 and 300i |
processing cancer patients' cells after high-dose chemotherapy |
Nexell Therapeutics Inc. (Irvine, Calif.) |
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DIACS SC |
processing cancer patients' cells after high-dose chemotherapy |
Dendreon Corp. (Seattle) |
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Diabetes |
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Continuous Glucose Monitoring System |
tissue glucose level monitoring |
MiniMed Inc. (Sylmar, Calif.) |
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Hepatitis |
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Hepatitis C Check |
hepatitis C home blood test |
Home Access Health Co. (Hoffman Estates, Ill.) |
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RIBA HCV 3.0 Strip Immunoblot Assay |
hepatitis C blood test |
Chiron Corp. (Emeryville, Calif.) |
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Heart Conditions |
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AngioJet System |
unblocking heart arteries before angioplasty |
Possis Medical Inc. (Minneapolis) |
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Eclipse TMR Holmium Laser System |
coronary artery disease |
Eclipse Medical Technologies Inc. (Sunnyvale, Calif.) |
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Ensite 3000 System |
diagnosing complex heart arrhythmias |
Endocardial Solutions Inc. (St. Paul, Minn.) |
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Nearsightedness |
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KeraVision Intacs |
mild nearsightedness |
KeraVision Inc. (Fremont, Calif.) |
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SVS Apex Plus Excimer Laser Workstation |
nearsightedness with or without astigmatism |
Summit Technology Inc. (Waltham, Mass.) |
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Other Conditions |
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Binax NOW |
detection of pneumonia-causing bacteria |
Binax Inc. (Portland, Maine) |
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PreVue B. burgdorferi Antibody Detection Assay |
test for Lyme disease |
Chembio Diagnostic Systems (Medford, N.Y.) |
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