1999 FDA Drug Approvals

Generic Name

Brand Name

Manufacturer

Indication

Preparation Type

Class

Alitretinoin Panretin Ligand Kaposi's sarcoma Topical Retinoin
Aminolevulinic Acid Levulan Guidelines Inc Actinic keratoses Solution Blue light radiation adjunct
Amprenavir Agenerase Glaxo Wellcome HIV Oral Protease inhibitor antiviral
ASA/Dipyridamole Aggrenox Boeringher-Ingelheim Reduce risk of stroke Oral Salicylate/Platelet aggregation inhibitor
Bexarotene Targretin Ligand Cutaneous T-cell Lymphoma Oral Retinoid receptor agonist
Caffeine Citrate Cafcit Roxane/Oread Pediatric Apnea in premature neonates Parenteral Caffeine
Ciclopirox Penlac Aventis Pharma Nail fungal infections Topical Antifungal
Cilostazol Pletal Otsuka America & Pharmacia Intermittent claudication Oral Phosphodiesterase III inhibitor
Dexmedetomidine Precedex Abbott ICU sedative Parenteral Alpha-2 agonist
Dofetilide Tikosyn Pfizer Atrial fibrillarion Oral Class III antiarrhythmic
Doxercalciferol Hectorol Bone Care International Hyperparathyroidism in dialysis Parenteral Synthetic vitamin D
Entacapone Comtan Orion Parkinson's disease Oral Levodopa/carbidopa adjunct
Epirubicin Ellence Pharmacia & Upjohn Breast cancer Parenteral Antineoplastic
Exemestane Aromasin Pharmacia & Upjohn Advanced breast cancer (postmenopausal) Oral Antineoplastic
Ferric gluconate complex Ferrlecit Iron deficiency anemia Makoff & Schein Parenteral Iron supplement
Gadoversetamide Optimark Mallinckrodt Liver imaging Parenteral MRI Enhaner
Ganirelix Antagon Organon Ovarian hyperstimulation LH surges Parenteral Gonadotropin releasing hormone antagonist
Gatifloxacin Tequin Bristol Myer Squibb Bacterial infections Oral/Parenteral Fluroquinolone
Ketotifen Zaditor Ciba Vision Allergic conjunctivitis Ocular Antihistamine
Levalbuterol Xopenox Sepracor Bronchospasm prevention Inhalation Albuterol isomer
Levetiractem Keppra UCB Pharma Partial onset seizures Oral Anticonvulsant
Levobupivacaine Chirocaine Darwin Discovery Anesthesia and pain management Parenteral Anesthestic
Lidocaine Lidoderm Hind Health Care Post-herpetic neuralgia Transdermal Analgesic
Miglitol Glyset Pharmacia & Upjohn Non-insulin dependent diabetes Oral Hypoglycemic agent
Moxifloxacin Avelox Bayer Bacterial infections Oral Fluoroquinolone
Nitric oxide Inomax Ino Therapeutics Hypoxic respiratory failure (neonatal) Inhalation Gas
Orlistat Xenical Roche Obesity Oral Lipase inhibitor
Oseltamivir Tamiflu Hoffman La Roche Influenza treatment:symptom onset <48 hrs Oral Antiviral
Pantoprazole Protonix Wyeth Ayerst Gastric ulcers Oral Proton pump inhibitor
Pemirolast Alamast Santen Allergic conjunctivitis Ocular Mast cell stabilizer
Pioglitazone Actos Takeda and Lilly Type 2 diabetes Oral Thiazolidinedione hypoglycemic
Poractant Alfa Curosurf Dey Labs Respiratory distress syndrome in premature infants Intratracheal Lung surfactant
Quinupristin/dalfopristin Synericid Rhone-Poulenc Vancomycin resistant Enterococcus Parenteral Antibiotic
Rabeprazole Aciphex Eisai and Janssen GERD, Duodenal ulcer Oral Proton pump inihibitor
Rapacuronium Raplon Organon General anesthesia adjunct Parenteral Skeletal muscle relaxant
Rofecoxib Vioxx Merck Osteoarhtirtis, acute pain Oral Cox-2 inhibitor NSAID
Rosiglitazone Avandia Smith Kline Beecham Type 2 diabetes Oral Thiazolidinedione hypoglycemic
Sirolimus Rapamune Wyeth-Ayerst Prevent organ rejection Parenteral Immunosuppressant
Technetium Tcc99m depreotide NeoTect Diatide & Nycomed Pulmonary imaging Parenteral Imaging agent
Temozolomide Temodar Schering-Plough Refractory anaplastic astrocytoma Oral Antineoplastic
Zaleplon Sonata Wyeth-Ayerst Insomnia Oral Hypnotic
Zanamivir Relenza Glaxo Wellcome Influenza A and B treatment Inhaled Neuraminidase inhibitor

                                        Prepared by Joyce Generali, Drug Information Center 1-5-2000

 

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