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2010ÄêFDAÅú×¼ÄÄЩÐÂÒ©? 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 assist in your search. Cardiology/Vascular Diseases Pradaxa (dabigatran etexilate mesylate); Boehringer Ingeleheim; For the risk reduction of stroke and embolism due to atrial fibrillation, Approved October 2010 Tekamlo (aliskiren + amlodipine); Novartis; For the treatment of hypertension, Approved August 2010 Tribenzor (olmesartan medoxomil + amlodipine + hydrochlorothiazide); Daiichi Sankyo; For the treatment of hypertension, Approved July 2010 Dermatology/Plastic Surgery Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010 Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010 Zyclara (imiquimod); Graceway; For the treatment of actinic keratoses of the face and scalp, Approved March 2010 Endocrinology Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010 Victoza (liraglutide); Novo Nordisk; For the treatment of type 2 diabetes mellitus, Approved January 2010 Gastroenterology Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010 Pancreaze (pancrelipase); Johnson & Johnson; For the treatment of exocrine pancreatic insufficiency, Approved April of 2010 Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010 Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010 Hematology Vpriv (velaglucerase alfa for injection); Shire; For the treatment of type 1 Gaucher disease, Approved March 2010 Immunology/Infectious Diseases Cayston (aztreonam for inhalation solution); Gilead Sciences; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010 Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010 Menveo (meningitis vaccine); Novartis; For the active immunization to prevent invasive meningococcal disease, Approved February 2010 Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April 2010 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine); Wyeth; For the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae, Approved February 2010 Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010 Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney transplant, Approved May 2010 Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 2010 Musculoskeletal Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved January 2010 Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010 Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010 Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved September 2010 Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010 Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010 Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010 Xeomin (incobotulinumtoxinA); Merz Pharmaceutical; For the treatment of cervical dystonia and blepharospasm, Approved July 2010 Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010 Xiaflex (collagenase clostridium histolyticum); Auxilium Pharmaceuticals; For the treatment of Dupuytren¡¯s contracture, Approved February 2010 Nephrology/Urology Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March 2010 Jalyn (dutasteride + tamsulosin); GlaxoSmithKline; For the treatment of benign prostatic hyperplasia, Approved June 2010 Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010 Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010 Xifaxan (rifaximin); Salix; For the treatment of hepatic encephalopathy, Approved March 2010 Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney transplant, Approved May 2010 Neurology Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010 Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010 Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October 2010 Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March 2010 Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010 Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of moderate to severe pain, Approved March 2010 Kapvay (clonidine hydrochloride); Shionogi Pharma; For the treatment of attention deficit hyperactivity disorder, Approved October 2010 Nuedexta (dextromethorphan hydrobromide and quinidine sulfate); Avanir Pharmaceuticals; For the treatment of pseudobulbar affect, Approved October 2010 Silenor (doxepin); Somaxon Pharma; For the treatment of insomnia, Approved March 2010 Sprix (ketorolac tromethamine); Roxro Pharma; For the treatment of moderate to severe pain, Approved May 2010 Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010 Vpriv (velaglucerase alfa for injection); Shire; For the treatment of type 1 Gaucher disease, Approved March 2010 Xifaxan (rifaximin); Salix; For the treatment of hepatic encephalopathy, Approved March 2010 Obstetrics/Gynecology ella (ulipristal acetate); HRA Pharma; For the emergency prevention of contraception, Approved August 2010 Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010 Natazia (estradiol valerate + dienogest); Bayer; For the prevention of contraception, Approved May 2010 Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010 Oncology Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010 Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010 Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010 Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010 Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010 Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010 Ophthalmology Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 2010 Otolaryngology Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April 2010 Pediatrics/Neonatology Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010 Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010 Kapvay (clonidine hydrochloride); Shionogi Pharma; For the treatment of attention deficit hyperactivity disorder, Approved October 2010 Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010 Pharmacology/Toxicology Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010 Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010 Psychiatry/Psychology Latuda (lurasidone); Sunovion; For the treatment of schizophrenia, Approved October 2010 Oleptro (trazodone hydrochloride); Labopharm; For the treatment of major depressive disorder, Approved February 2010 Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010 Pulmonary/Respiratory Diseases Cayston (aztreonam for inhalation solution); Gilead Sciences; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010 Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010 Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010 Rheumatology Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved January 2010 Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010 Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010 Trauma/Emergency Medicine Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010 ÐÅÏ¢À´Ô´: CenterWatch http://www.centerwatch.com/drug-information/fda-approvals/ |
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