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FDA Approved Drugs
The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale
in the United States. Drug information typically includes the drug name, approval status, indication of use, and
clinical trial results.
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Find out more about the types of drugs included in this listing.
1999
Cardiology/Vascular Diseases
Lescol (fluvastatin sodium) capsules, Rx; Novartis;
Treatment for the reduction of triglycerides, Approved June 1999
Mevacor (lovastatin) tablets; Merck;
Treatment for primary prevention of coronary heart disease, Approved March 1999
Niaspan; Kos Pharmaceuticals;
Niacin extended-release tablets, October 28, 1999
Dental and Oral Health
Atridox; Atrix Laboratories;
Treatment of chronic adult periodontitis, Approved January 1999
Dermatology
Lamisil (terbinafine hydrochloride) Dermagel, 1%; Novartis;
Treatment for tinea pedis (athlete's foot), Approved March 1999
Luxiq (betamethasone valerate) Foam; Connetics Corporation;
Treatment for dermatoses of scalp, Approved June 1999
Endocrinology
ACTOS; Takeda;
Treatment for type II diabetes, Approved July 1999
Aggrenox; Boehringer Ingelheim;
Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke, Approved November 1999
Aromasin Tablets; Pharmacia & Upjohn;
Exemestane Tablets, 25 mg, October 21, 1999
Avandia (rosiglitazone maleate); SmithKline Beecham;
Treatment for type II diabetes mellitus, Approved June 1999
Cernevit; Baxter Healthcare;
For the treatment of vitamin deficiency, Approved April 1999.
Climara; Berlex Laboratories;
For the prevention of postmenopausal osteoporosis (loss of bone mass), Approved June 1999
Doxil (doxorubicin HCl liposome injection); Alza;
Treatment for ovarian cancer that is refractory to other first-line therapies, Approved June 1999
Ellence; Pharmacia & Upjohn;
epirubicin hydrochloride, Approved September 1999
Ethyol (amifostine); U.S. Bioscience, Alza;
Treatment for xerostomia (dry mouth) due to radiation, Approved June 1999
Evista (raloxifene hydrochloride); Eli Lilly;
Osteoporosis treatment, Approved September 1999
Femhrt Tablets; Parke-Davis;
Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg), October 15, 1999
Ortho-Prefest; Ortho-McNeil Pharmaceutical, R.W. Johnson;
17 beta estradiol/17 beta estradiol norgestimate tablets, October 22, 1999
Xenical/Orlistat Capsules; Roche;
Treatment for obesity management, Approved April 1999
Family Medicine
Accolate; AstraZeneca;
zafirlukast, 10 mg and 20 mg tablets., Approved September 1999
Aggrenox; Boehringer Ingelheim;
Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke, Approved November 1999
Aromasin Tablets; Pharmacia & Upjohn;
Exemestane Tablets, 25 mg, October 21, 1999
Comtan; Novartis;
200mg entacapone tablets, October 19, 1999
Ellence; Pharmacia & Upjohn;
epirubicin hydrochloride, Approved September 1999
Evista (raloxifene hydrochloride); Eli Lilly;
Osteoporosis treatment, Approved September 1999
Femhrt Tablets; Parke-Davis;
Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg), October 15, 1999
Keppra; UCB;
Levetiracetam tablets for adjunctive treatment of partial onset seizures in adults with epilepsy, Approved November 1999
Ortho-Prefest; Ortho-McNeil Pharmaceutical, R.W. Johnson;
17 beta estradiol/17 beta estradiol norgestimate tablets, October 22, 1999
Synercid I.V.; Rhone Poulenc Rorer;
quinupristin and dalfopristin for injection, Approved September 1999
Gastroenterology
Prevpac; TAP Pharmaceuticals;
Treatment for eradication of H. pylori, Approved February 1999
Genetic Disease
Keppra; UCB;
Levetiracetam tablets for adjunctive treatment of partial onset seizures in adults with epilepsy, Approved November 1999
Hematology
Aggrenox; Boehringer Ingelheim;
Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke, Approved November 1999
Busulflex; Orphan Medical;
For use in combination for the treatment of leukemia, Approved February 1999
Ferrlecit; R&D Laboratories;
For the treatment of iron deficiency anemia., Approved February 1999
Fragmin; Pharmacia & Upjohn;
Treatment of prophylaxis of deep vein thrombosis (DVT), Approved March 1999
Lovenox (enoxaparin sodium) Injection; Rhone Poulenc Rorer;
Treatment for acute deep vein thrombosis, Approved January 1999
Immunology
Agenerase (amprenavir); GlaxoSmithKline;
For the treatment of HIV-1 infection., Approved April 1999
Cleocin (clindamycin phosphate); Pharmacia & Upjohn;
Treatment for bacterial vaginosis, Approved August 1999
Famvir (famciclovir); SmithKline Beecham;
Treatment for Herpes Simplex Infections in HIV-infected patients, Approved January 1999
Norvir (ritonavir); Abbott Laboratories;
Treatment for HIV infection, Approved June 1999
Panretin Gel; Ligand Pharmaceuticals;
Treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma., Approved June 1999
Rapamune (sirolimus) oral solution; Wyeth;
Oral solution of sirolimus, Approved September 1999
Relenza; GlaxoSmithKline;
Treatment for uncomplicated acute illness due to influenza virus, Approved July 1999
Synercid I.V.; Rhone Poulenc Rorer;
quinupristin and dalfopristin for injection, Approved September 1999
Tamiflu capsule; Roche;
Oseltamivir phosphate capsule, October 27, 1999
Vistide (cidofovir); Gilead;
For the treatment of cytomegalovirus (CMV) retinitis, Approved March 1999
Infections and Infectious Diseases
Nasonex Nasal Spray; Schering-Plough;
Treatment of seasonal allergic rhinitis, Approved January 1999
Rhinocort Aqua Nasal Spray; AstraZeneca;
A nasal spray containing budesonide, Approved October 1999
Synercid I.V.; Rhone Poulenc Rorer;
quinupristin and dalfopristin for injection, Approved September 1999
Tamiflu capsule; Roche;
Oseltamivir phosphate capsule, October 27, 1999
Musculoskeletal
Evista (raloxifene hydrochloride); Eli Lilly;
Osteoporosis treatment, Approved September 1999
Femhrt Tablets; Parke-Davis;
Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg), October 15, 1999
Nephrology
Ditropan XL (oxybutynin chloride); Alza;
Treatment for overactive bladder, Approved June 1999
Levaquin; R.W. Johnson;
Treatment for urinary tract infection, Approved July 1999
Tequin; Bristol-Myers Squibb;
Tequin (Injectable and Tablet), December, 1999
Neurology
Aggrenox; Boehringer Ingelheim;
Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke, Approved November 1999
Cenestin; Duramed Pharmaceuticals;
Treatment for symptoms associated with menopause, Approved July 1999
Comtan; Novartis;
200mg entacapone tablets, October 19, 1999
Keppra; UCB;
Levetiracetam tablets for adjunctive treatment of partial onset seizures in adults with epilepsy, Approved November 1999
Lamictal (lamotrigine) Chewable Dispersible Tablets; GlaxoSmithKline;
Treatment for epileptic seizures, Approved June 1999
Lidoderm Patch (lidocaine patch 5% ); Hind Health Care;
Treatment of pain in post-herpetic neuralgia, Approved June 1999
Sonata; American Home Products;
Treatment fo insomnia, Approved August 1999
Topamax (topiramate); Ortho-McNeil Pharmaceutical;
Treatment for epilepsy in pediatric patients, Approved July 1999
Obstetrics/Gynecology (Women’s Health)
Aromasin Tablets; Pharmacia & Upjohn;
Exemestane Tablets, 25 mg, October 21, 1999
Cenestin; Duramed Pharmaceuticals;
Treatment for symptoms associated with menopause, Approved July 1999
Cenestin; Duramed Pharmaceuticals;
Treatment for relief of vasomotor symptoms due to menopause, Approved March 1999
Cleocin (clindamycin phosphate); Pharmacia & Upjohn;
Treatment for bacterial vaginosis, Approved August 1999
Climara; Berlex Laboratories;
For the prevention of postmenopausal osteoporosis (loss of bone mass), Approved June 1999
Doxil (doxorubicin HCl liposome injection); Alza;
Treatment for ovarian cancer that is refractory to other first-line therapies, Approved June 1999
Ellence; Pharmacia & Upjohn;
epirubicin hydrochloride, Approved September 1999
Estradiol Transdermal System; Wyeth;
Transdermal patch system for the treatement of vulvar vaginal atrophy and vasomotor symptoms., Approved September 1999
Evista (raloxifene hydrochloride); Eli Lilly;
Osteoporosis treatment, Approved September 1999
Femhrt Tablets; Parke-Davis;
Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg), October 15, 1999
Lupron Depot (leuprolide acetate for depot suspension); TAP Pharmaceuticals;
Treatment for endometriosis and uterine fibroids, Approved June 1999
Ortho-Prefest; Ortho-McNeil Pharmaceutical, R.W. Johnson;
17 beta estradiol/17 beta estradiol norgestimate tablets, October 22, 1999
Tequin; Bristol-Myers Squibb;
Tequin (Injectable and Tablet), December, 1999
Oncology
Aromasin Tablets; Pharmacia & Upjohn;
Exemestane Tablets, 25 mg, October 21, 1999
Busulflex; Orphan Medical;
For use in combination for the treatment of leukemia, Approved February 1999
Doxil (doxorubicin HCl liposome injection); Alza;
Treatment for ovarian cancer that is refractory to other first-line therapies, Approved June 1999
Ellence; Pharmacia & Upjohn;
epirubicin hydrochloride, Approved September 1999
Ethyol (amifostine); U.S. Bioscience, Alza;
Treatment for xerostomia (dry mouth) due to radiation, Approved June 1999
Temodar; Schering-Plough;
Treatment for refractory anaplastic astrocytoma, Approved August 1999
UVADEX Sterile Solution; Therakos;
Treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), Approved February 1999
Zofran; GlaxoSmithKline;
Treatment for the prevention of chemotherapy and radiation-induced nausea, Approved January 1999
Ophthalmology
Alamast; Santen;
pemirolast potassium ophthalmic solution, Approved September 1999
ZADITOR; Ciba Vision;
Treatment for the prevention of itching of the eye, Approved July 1999
Otolaryngology (Ear, Nose, Throat)
Ethyol (amifostine); U.S. Bioscience, Alza;
Treatment for xerostomia (dry mouth) due to radiation, Approved June 1999
Pediatrics/Neonatology
Amoxil (amoxicillin); SmithKline Beecham;
Treatment (antibiotic) for common bacteria, Approved July 1999
Topamax (topiramate); Ortho-McNeil Pharmaceutical;
Treatment for epilepsy in pediatric patients, Approved July 1999
Pharmacology/Toxicology
Raplon; Organon;
Adjunct to general anesthesia during surgical procedures, Approved August 1999
Psychiatry/Psychology
Effexor (venlafaxin HCL); Wyeth;
Treatment for generalized anxiety disorder, Approved March 1999
Paxil CR (paroxetine hydrochloride); SmithKline Beecham;
Treatment for depression, Approved March 1999
Sonata; American Home Products;
Treatment fo insomnia, Approved August 1999
Pulmonary/Respiratory Diseases
Accolate; AstraZeneca;
zafirlukast, 10 mg and 20 mg tablets., Approved September 1999
Cafcit Injection; Roxane Laboratories;
For the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age., Approved September 1999
Proventil HFA Inhalation Aerosol; 3M Pharmaceuticals;
Treatment or prevention of bronchospasm, Approved June 1999
Rhinocort Aqua Nasal Spray; AstraZeneca;
A nasal spray containing budesonide, Approved October 1999
Tequin; Bristol-Myers Squibb;
Tequin (Injectable and Tablet), December, 1999
Tikosyn Capsules; Pfizer;
Capsules of dofetilide, Approved October 1999
Rheumatology
Lodine XL (etodolac); Wyeth;
Treatment for the signs and symptoms of osteoarthritis and rheumatoid arthritis, Approved May 1999
Vaccines
Synercid I.V.; Rhone Poulenc Rorer;
quinupristin and dalfopristin for injection, Approved September 1999
Tamiflu capsule; Roche;
Oseltamivir phosphate capsule, October 27, 1999