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2013 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

Adempas (riociguat); Bayer Healthcare Pharmaceuticals; For the treatment of Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, Approved October 2013

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

Opsumit (macitentan); Actelion Pharmaceuticals; For the treatment of pulmonary arterial hypertension, Approved October 2013

Varithena (polidocanol injectable foam); BTG plc; For the treatment of varicose veins, November 2013

Dermatology

Luzu (luliconazole) Cream 1%; Valeant Pharmaceuticals; For the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, November of 2013

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

Varithena (polidocanol injectable foam); BTG plc; For the treatment of varicose veins, November 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

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 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

Anoro Ellipta (umeclidinium and vilanterol inhalation powder); GlaxoSmithKline; For the maintenance treatment of chronic obstructive pulmonary disease, Approved December of 2013

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

Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets); Duchesnay USA; For the treatment of nausea and vomiting of pregnancy, Approved April 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 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

Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 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

Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 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

Xiaflex (collagenase clostridium histolyticum); Auxilium; For the treatment of Peyronie's disease, Approved December of 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

Tretten (Coagulation Factor XIII A-Subunit [Recombinant]); Novo Nordisk; For the treatment of congenital factor XIII (FXIII) A-subunit deficiency, Approved December of 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

Gazyva (obinutuzumab); Genentech; For the treatment of previously untreated chronic lymphocytic leukemia, Approved October of 2013

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of mantle cell lymphoma, Approved November of 2013

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

Tretten (Coagulation Factor XIII A-Subunit [Recombinant]); Novo Nordisk; For the treatment of congenital factor XIII (FXIII) A-subunit deficiency, Approved December of 2013

Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013

Hepatology (Liver, Pancreatic, Gall Bladder)

Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 2013

Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 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

Luzu (luliconazole) Cream 1%; Valeant Pharmaceuticals; For the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, November of 2013

Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 2013

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

Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 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

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 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

Aptiom (eslicarbazepine acetate); Sunovion Pharmaceuticals; For the adjunctive treatment of partial-onset seizures, Approved November 2013

Fetzima (levomilnacipran); Forest Laboratories; 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

Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules; Zogenix; For the management of severe pain, Approved October 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

Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets); Duchesnay USA; For the treatment of nausea and vomiting of pregnancy, Approved April 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 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

Gazyva (obinutuzumab); Genentech; For the treatment of previously untreated chronic lymphocytic leukemia, Approved October of 2013

Gilotrif (afatinib); Boehringer Ingelheim; For the treatment of metastatic non-small cell lung cancer with EGFR mutations, Approved July 2013

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of mantle cell lymphoma, Approved November of 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

Podiatry

Luzu (luliconazole) Cream 1%; Valeant Pharmaceuticals; For the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, November of 2013

Psychiatry/Psychology

Brintellix (vortioxetine); Takeda Pharmaceuticals USA; For the treatment of Major Depressive Disorder, Approved October 2013

Fetzima (levomilnacipran); Forest Laboratories; 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

Adempas (riociguat); Bayer Healthcare Pharmaceuticals; For the treatment of Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, Approved October 2013

Anoro Ellipta (umeclidinium and vilanterol inhalation powder); GlaxoSmithKline; For the maintenance treatment of chronic obstructive pulmonary disease, Approved December of 2013

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

Opsumit (macitentan); Actelion Pharmaceuticals; For the treatment of pulmonary arterial hypertension, Approved October 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

Xiaflex (collagenase clostridium histolyticum); Auxilium; For the treatment of Peyronie's disease, Approved December of 2013

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

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