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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.
Review descriptions for our medical therapeutic area list to help
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Find out more about the types of drugs included in this listing.
2007
Cardiology/Vascular Diseases
Azor (amlodipine besylate; olmesartan medoxomil); Daiichi Sankyo;
For the treatment of hypertension, Approved September 2007
Fenofibrate; LifeCycle Pharma;
For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia, Approved August 2007
Letairis (ambrisentan); Gilead;
For the treatment of pulmonary arterial hypertension, Approved June 2007
Soliris (eculizumab); Alexion;
For the treatment of paroxysmal nocturnal hemoglobinuria, Approved March 2007
Tekturna (aliskiren); Novartis;
For the treatment of hypertension, Approved March 2007
Dermatology
Altabax (retapamulin); GlaxoSmithKline;
For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007
Extina (ketoconazole); Stiefel;
For the treatment of seborrheic dermatitis, Approved June 2007
Xyzal (levocetirizine dihydrochloride); UCB;
For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Endocrinology
Evamist (estradiol); Vivus;
For the treatment of moderate to severe vasomotor symptoms due to menopause, Approved July 2007
Fenofibrate; LifeCycle Pharma;
For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia, Approved August 2007
Somatuline Depot (lanreotide acetate); Beaufour Ipsen;
For the treatment of acromegaly, Approved August 2007
Supprelin LA (histrelin acetate); Indevus Pharmaceuticals;
For the treatment of central precocious puberty, Approved May 2007
Family Medicine
Amrix (cyclobenzaprine hydrochloride extended release); Cephalon;
For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007
Azor (amlodipine besylate; olmesartan medoxomil); Daiichi Sankyo;
For the treatment of hypertension, Approved September 2007
Doribax (doripenem); Johnson & Johnson;
For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007
Evamist (estradiol); Vivus;
For the treatment of moderate to severe vasomotor symptoms due to menopause, Approved July 2007
Evista (raloxifene hydrochloride); Eli Lilly;
For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007
Exelon (rivastigmine tartrate); Novartis;
For the treatment of Alzheimer's and Parkinson's disease-related dementia, Approved July 2007
Hycamtin (topotecan hydrochloride); GlaxoSmithKline;
For the treatment of small cell lung cancer, Approved October 2007
Isentress (raltegravir); Merck;
For the treatment of HIV-1, Approved October 2007
Ixempra (ixabepilone); Bristol-Myers Squibb;
For the treatment of breast cancer, Approved October 2007
Letairis (ambrisentan); Gilead;
For the treatment of pulmonary arterial hypertension, Approved June 2007
Neupro (rotigotine); Schwarz Pharma;
For the treatment of Parkinson's disease, Approved May 2007
Reclast (zoledronic acid); Novartis;
For the treatment of postmenopausal osteoporosis, Approved August 2007
Renvela (sevelamer carbonate); Genzyme;
For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved October 2007
Selzentry (maraviroc); Pfizer;
For the treatment of CCR5-tropic HIV-1, Approved August 2007
Soliris (eculizumab); Alexion;
For the treatment of paroxysmal nocturnal hemoglobinuria, Approved March 2007
Tekturna (aliskiren); Novartis;
For the treatment of hypertension, Approved March 2007
Torisel (temsirolimus); Wyeth;
For the treatment of renal cell carcinoma, Approved May 2007
Tykerb (lapatinib); GlaxoSmithKline;
For the treatment of breast cancer, Approved March 2007
Vyvanse (Lisdexamfetamine Dimesylate); New River;
For the treatment of Attention-Deficit/Hyperactivity Disorder, Approved February 2007
Hematology
Kuvan (sapropterin dihydrochloride); BioMarin Pharmaceuticals;
For the treatment of hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria, Approved December 2007
Mircera (methoxy polyethylene glycol-epoetin beta); Roche;
For the treatment of anemia associated with chronic renal failure, Approved November 2007
Soliris (eculizumab); Alexion;
For the treatment of paroxysmal nocturnal hemoglobinuria, Approved March 2007
Hepatology (Liver, Pancreatic, Gall Bladder)
Torisel (temsirolimus); Wyeth;
For the treatment of renal cell carcinoma, Approved May 2007
Immunology
Altabax (retapamulin); GlaxoSmithKline;
For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007
AzaSite (azithromycin); InSite Vision;
For the treatment of bacterial conjunctivitis, Approved April 2007
Doribax (doripenem); Johnson & Johnson;
For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007
Extina (ketoconazole); Stiefel;
For the treatment of seborrheic dermatitis, Approved June 2007
Isentress (raltegravir); Merck;
For the treatment of HIV-1, Approved October 2007
Selzentry (maraviroc); Pfizer;
For the treatment of CCR5-tropic HIV-1, Approved August 2007
Veramyst (fluticasone furoate); GlaxoSmithKline;
For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007
Xyzal (levocetirizine dihydrochloride); UCB;
For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Infections and Infectious Diseases
Isentress (raltegravir); Merck;
For the treatment of HIV-1, Approved October 2007
Selzentry (maraviroc); Pfizer;
For the treatment of CCR5-tropic HIV-1, Approved August 2007
Veramyst (fluticasone furoate); GlaxoSmithKline;
For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007
Xyzal (levocetirizine dihydrochloride); UCB;
For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Musculoskeletal
Amrix (cyclobenzaprine hydrochloride extended release); Cephalon;
For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007
Evista (raloxifene hydrochloride); Eli Lilly;
For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007
Reclast (zoledronic acid); Novartis;
For the treatment of postmenopausal osteoporosis, Approved August 2007
Reclast (zoledronic acid); Novartis;
For the treatment of Paget's disease, Approved April 2007
Somatuline Depot (lanreotide acetate); Beaufour Ipsen;
For the treatment of acromegaly, Approved August 2007
Nephrology
Doribax (doripenem); Johnson & Johnson;
For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007
Mircera (methoxy polyethylene glycol-epoetin beta); Roche;
For the treatment of anemia associated with chronic renal failure, Approved November 2007
Renvela (sevelamer carbonate); Genzyme;
For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved October 2007
Torisel (temsirolimus); Wyeth;
For the treatment of renal cell carcinoma, Approved May 2007
Neurology
Amrix (cyclobenzaprine hydrochloride extended release); Cephalon;
For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007
Exelon (rivastigmine tartrate); Novartis;
For the treatment of Alzheimer's and Parkinson's disease-related dementia, Approved July 2007
Neupro (rotigotine); Schwarz Pharma;
For the treatment of Parkinson's disease, Approved May 2007
Nuvigil (armodafinil); Cephalon;
For the treatment of excessive sleepiness, Approved June 2007
Vyvanse (Lisdexamfetamine Dimesylate); New River;
For the treatment of Attention-Deficit/Hyperactivity Disorder, Approved February 2007
Obstetrics/Gynecology (Women’s Health)
Evamist (estradiol); Vivus;
For the treatment of moderate to severe vasomotor symptoms due to menopause, Approved July 2007
Evista (raloxifene hydrochloride); Eli Lilly;
For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007
Reclast (zoledronic acid); Novartis;
For the treatment of postmenopausal osteoporosis, Approved August 2007
Oncology
Evista (raloxifene hydrochloride); Eli Lilly;
For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007
Hycamtin (topotecan hydrochloride); GlaxoSmithKline;
For the treatment of small cell lung cancer, Approved October 2007
Ixempra (ixabepilone); Bristol-Myers Squibb;
For the treatment of breast cancer, Approved October 2007
Tasigna (nilotinib hydrochloride monohydrate); Novartis;
For the treatment of chronic myelogenous leukemia, Approved October 2007
Torisel (temsirolimus); Wyeth;
For the treatment of renal cell carcinoma, Approved May 2007
Tykerb (lapatinib); GlaxoSmithKline;
For the treatment of breast cancer, Approved March 2007
Ophthalmology
AzaSite (azithromycin); InSite Vision;
For the treatment of bacterial conjunctivitis, Approved April 2007
Orthopedics/Orthopedic Surgery
Amrix (cyclobenzaprine hydrochloride extended release); Cephalon;
For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007
Otolaryngology (Ear, Nose, Throat)
Veramyst (fluticasone furoate); GlaxoSmithKline;
For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007
Xyzal (levocetirizine dihydrochloride); UCB;
For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Pediatrics/Neonatology
Altabax (retapamulin); GlaxoSmithKline;
For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007
Supprelin LA (histrelin acetate); Indevus Pharmaceuticals;
For the treatment of central precocious puberty, Approved May 2007
Veramyst (fluticasone furoate); GlaxoSmithKline;
For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007
Vyvanse (Lisdexamfetamine Dimesylate); New River;
For the treatment of Attention-Deficit/Hyperactivity Disorder, Approved February 2007
Xyzal (levocetirizine dihydrochloride); UCB;
For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Zingo (lidocaine hydrochloride monohydrate); Anesiva;
For local analgesia prior to venipuncture or peripheral intravenous cannulation,
in children 3 to 18 years of age, Approved August 2007
Psychiatry/Psychology
Vyvanse (Lisdexamfetamine Dimesylate); New River;
For the treatment of Attention-Deficit/Hyperactivity Disorder, Approved February 2007
Pulmonary/Respiratory Diseases
Letairis (ambrisentan); Gilead;
For the treatment of pulmonary arterial hypertension, Approved June 2007
Xyzal (levocetirizine dihydrochloride); UCB;
For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Urology
Doribax (doripenem); Johnson & Johnson;
For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007
