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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.
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
Mekinist (trametinib); GlaxoSmithKline;
For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013
Mirvaso (brimonidine); Galderma Labs;
For the treatment of facial erythema of rosacea, Approved August 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma;
For the treatment of recurrent herpes labialis in adults, Approved April 2013
Tafinlar (dabrafenib); GlaxoSmithKline;
For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics;
For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013
Devices
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline;
For the treatment of chronic obstructive pulmonary disease, Approved May 2013
Endocrinology
Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals;
For the treatment of vasomotor symptoms of menopause, Approved July 2013
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 conception, 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
Simponi (golimumab); Janssen Biotech;
For the treatment of ulcerative colitis, Aproved May 2013
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
Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals;
For the treatment of iron deficiency anemia, Approved July 2013
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
Revlimid (lenalidomide); Celgene;
For the treatment of mantle cell lymphoma, Approved June 2013
Rixubis (Coagulation Factor IX (Recombinant)]; Baxter International;
For the routine prophylaxis and control of hemophilia B, Approved June 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics;
For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 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
Simponi (golimumab); Janssen Biotech;
For the treatment of ulcerative colitis, Aproved May 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
Tivicay (dolutegravir); ViiV HealthCare;
For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 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
Vibativ (telavancin); Theravance;
For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 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
Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals;
For the treatment of iron deficiency anemia, Approved July 2013
Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals;
For the management of nephropathic cystinosis, Approved May 2013
Neurology
Fetzima (levomilnacipran); Forest Labs;
For the treatment of major depressive disorder, Approved July 2013
Nymalize (nimodipine); Arbor Pharmaceuticals;
For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013
Trokendi XR (topiramate); Supernus Pharmaceuticals;
For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013
Zubsolv (buprenorphine and naloxone); Orexo AB;
For the maintenance treatment of opioid dependence, Approved July 2013
Nutrition and Weight Loss
Nesina (alogliptin); Takeda;
For the treatment of type II diabetes mellitus, Approved January 2013
Obstetrics/Gynecology (Women’s Health)
Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals;
For the treatment of vasomotor symptoms of menopause, Approved July 2013
Kadcyla (ado-trastuzumab emtansine); Genentech;
For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Lo Minastrin, (norethindrone acetate, ethinyl estradiol, ferrous fumarate); Warner Chilcott;
For the prevention of pregnancy, Approved July 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 conception, Approved April 2013
Oncology
Gilotrif (afatinib); Boehringer Ingelheim;
For the treatment of metastatic non-small cell lung cancer with EGFR mutations, Approved July 2013
Kadcyla (ado-trastuzumab emtansine); Genentech;
For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Mekinist (trametinib); GlaxoSmithKline;
For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013
Pomalyst (pomalidomide); Celgene;
For the treatment of relapsed and refractory multiple myeloma, Approved February 2013
Revlimid (lenalidomide); Celgene;
For the treatment of mantle cell lymphoma, Approved June 2013
Stivarga (regorafenib); Bayer;
For the treatment of gastrointestinal stromal tumor, Approved February 2013
Tafinlar (dabrafenib); GlaxoSmithKline;
For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics;
For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013
Xgeva (denosumab); Amgen;
For the treatment of giant cell tumor of bone, Approved June 2013
Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals;
For the treatment of prostate cancer with bone metastases, Approved May 2013
Orthopedics/Orthopedic Surgery
Xgeva (denosumab); Amgen;
For the treatment of giant cell tumor of bone, Approved June 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
Tivicay (dolutegravir); ViiV HealthCare;
For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 2013
Trokendi XR (topiramate); Supernus Pharmaceuticals;
For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013
Pharmacology/Toxicology
Kcentra (Prothrombin Complex Concentrate); CSL Behring;
For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013
Psychiatry/Psychology
Fetzima (levomilnacipran); Forest Labs;
For the treatment of major depressive disorder, Approved July 2013
Zubsolv (buprenorphine and naloxone); Orexo AB;
For the maintenance treatment of opioid dependence, Approved July 2013
Pulmonary/Respiratory Diseases
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline;
For the treatment of chronic obstructive pulmonary disease, Approved May 2013
Vibativ (telavancin); Theravance;
For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 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
