2010 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.

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Find out more about the types of drugs included in this listing.

Cardiology/Vascular Diseases

Amturnide (aliskiren + amlodipine + hydrochlorothiazide); Novartis; For the treatment of uncontrolled hypertension, Approved December 2010

Pradaxa (dabigatran etexilate mesylate); Boehringer Ingelheim; 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

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

Fortesta (testosterone gel); Endo Pharmaceuticals; For the treatment of hypogonadism, Approved December 2010

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

Family Medicine

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

Amturnide (aliskiren + amlodipine + hydrochlorothiazide); Novartis; For the treatment of uncontrolled hypertension, Approved December 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010

Butrans (buprenorphine) Transdermal System; Purdue Pharma; moderate to severe chronic pain, Approved July 2010

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

Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010

Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of moderate to severe pain, Approved March 2010

Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved September 2010

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

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

Kapvay (clonidine hydrochloride); Shionogi; For the treatment of attention deficit hyperactivity disorder, Approved October 2010

Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010

Oleptro (trazodone hydrochloride); Labopharm; For the treatment of major depressive disorder, Approved February 2010

Pradaxa (dabigatran etexilate mesylate); Boehringer Ingelheim; For the risk reduction of stroke and embolism due to atrial fibrillation, Approved October 2010

Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010

Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 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

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 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

Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010

Victoza (liraglutide); Novo Nordisk; For the treatment of type 2 diabetes mellitus, Approved January 2010

Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010

Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 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

Genetic Disease

Cayston (aztreonam for inhalation solution); Gilead; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010

Vpriv (velaglucerase alfa for injection); Shire Pharmaceuticals; For the treatment of type 1 Gaucher disease, Approved March 2010

Hematology

Vpriv (velaglucerase alfa for injection); Shire Pharmaceuticals; For the treatment of type 1 Gaucher disease, Approved March 2010

Hepatology (Liver, Pancreatic, Gall Bladder)

Cayston (aztreonam for inhalation solution); Gilead; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010

Immunology

Cayston (aztreonam for inhalation solution); Gilead; 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

Infections and Infectious Diseases

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

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 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

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 Pharmaceuticals; 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

Butrans (buprenorphine) Transdermal System; Purdue Pharma; moderate to severe chronic pain, Approved July 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; 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 Pharmaceuticals; For the treatment of type 1 Gaucher disease, Approved March 2010

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of hepatic encephalopathy, Approved March 2010

Obstetrics/Gynecology (Women’s Health)

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 (Ear, Nose, Throat)

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; 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; 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

Sleep

Silenor (doxepin); Somaxon Pharma; For the treatment of insomnia, Approved March 2010

Trauma (Emergency, Injury, Surgery)

Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010

Urology

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

Vaccines

Menveo (meningitis vaccine); Novartis; For the active immunization to prevent invasive meningococcal disease, Approved February 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