Clinical Trial Resource Center


Clinical Trial Resource Center

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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.

2014

Cardiology/Vascular Diseases

Epanova (omega-3-carboxylic acids); AstraZeneca; For the treatment of severe hypertriglyceridemia, Approved May 2014

Zontivity (vorapaxar); Merck; For the reduction of thrombotic cardiovascular events, Approved May 2014

Dermatology

Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved May 2014

Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of the toenails, Approved June 2014

Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014

Orbactiv (oritavancin); The Medicines Company; For the treatment of acute bacterial skin and skin structure infections, Approved August 2014

Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and skin structure infections, Approved June 2014

Endocrinology

Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved June 2014

Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014

Farxiga (dapagliflozin); Bristol-Myers Squibb; For the treatment of type II diabetes, January of 2014

Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2014

Natesto, (testosterone) nasal gel; Trimel Pharmaceuticals; For the treatment of deficiency or absence of endogenous testosterone, Approved May 2014

Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014

Vogelxo (testosterone) gel; Upsher-Smith; For males with a deficiency or absence of endogenous testosterone, Approved June 2014

Family Medicine

Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved June 2014

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014

Belsomra (suvorexant); Merck; For the treatment of insomnia, Approved August 2014

Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014

Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved May 2014

Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014

Farxiga (dapagliflozin); Bristol-Myers Squibb; For the treatment of type II diabetes, January of 2014

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2014

Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014

Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014

Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired generalized lipodystrophy, Approved February of 2014

Natesto, (testosterone) nasal gel; Trimel Pharmaceuticals; For the treatment of deficiency or absence of endogenous testosterone, Approved May 2014

Northera (droxidopa); Chelsea Therapeutics; For the treatment of neurogenic orthostatic hypotension, Approved February 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014

Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt Pharmaceuticals; For the management of acute pain, Approved March 2014

Gastroenterology

Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014

Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014

Genetic Disease

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved February 2014

Healthy Volunteers

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Hematology

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014

Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ; Biogen IDEC.; For the treatment of hemophillia A, Approved June 2014

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia, Approved February 2014

Ruconest (C1 esterase inhibitor [recombinant]); Pharming Group; For the treatment of hereditary angioedema, Approved July 2014

Sylvant (siltuximab); Janssen Biotech; For the treatment of multicentric Castleman’s disease, Approved April 2014

Zontivity (vorapaxar); Merck; For the reduction of thrombotic cardiovascular events, Approved May 2014

Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014

Immunology

Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2014

Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired generalized lipodystrophy, Approved February of 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Sylvant (siltuximab); Janssen Biotech; For the treatment of multicentric Castleman’s disease, Approved April 2014

Infections and Infectious Diseases

Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved May 2014

Impavido (miltefosine); Knight Therapeutics; For the treatment of visceral, cutaneous and mucosal leishmaniasis, Approved March 2014

Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of the toenails, Approved June 2014

Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014

Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014

Orbactiv (oritavancin); The Medicines Company; For the treatment of acute bacterial skin and skin structure infections, Approved August 2014

Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and skin structure infections, Approved June 2014

Musculoskeletal

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved February 2014

Neurology

Belsomra (suvorexant); Merck; For the treatment of insomnia, Approved August 2014

Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in the totally blind, January 2014

Northera (droxidopa); Chelsea Therapeutics; For the treatment of neurogenic orthostatic hypotension, Approved February 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014

Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt Pharmaceuticals; For the management of acute pain, Approved March 2014

Nutrition and Weight Loss

Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2014

Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014

Obstetrics/Gynecology (Women’s Health)

Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014

Oncology

Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014

Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia, Approved February 2014

Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014

Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014

Ophthalmology

Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in the totally blind, January 2014

Omidria (phenylephrine and ketorolac injection); Omeros; For use during eye surgery to prevent intraoperative miosis and reduce post-operative pain, Approved June 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Orthopedics/Orthopedic Surgery

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Otolaryngology (Ear, Nose, Throat)

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Pediatrics/Neonatology

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved February 2014

Pharmacology/Toxicology

Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014

Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired generalized lipodystrophy, Approved February of 2014

Psychiatry/Psychology

Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014

Pulmonary/Respiratory Diseases

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Striverdi Respimat (olodaterol); Boehringer Ingelheim; For the treatment of chronic obstructive pulmonary disease , Approved July 2014

Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014

Rheumatology

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Sleep

Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in the totally blind, January 2014