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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 assist in your search.

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

2013

Cardiology/Vascular Diseases

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Dermatology

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Devices

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Endocrinology

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Family Medicine

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of contraception, Approved April 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Gastroenterology

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Genetic Disease

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Healthy Volunteers

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Hematology

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Immunology

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

Infections and Infectious Diseases

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

Musculoskeletal

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Nephrology

Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals; For the management of nephropathic cystinosis, Approved May 2013

Neurology

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Nutrition and Weight Loss

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Obstetrics/Gynecology (Women’s Health)

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of contraception, Approved April 2013

Oncology

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013

Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013

Pediatrics/Neonatology

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Pharmacology/Toxicology

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Pulmonary/Respiratory Diseases

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Rheumatology

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Trauma (Emergency, Injury, Surgery)

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Urology

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013

Vaccines

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013