2014 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
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
Keytruda (pembrolizumab); Merck;
For the treatment of unresectable or metastatic melanoma, Approved September 2014
Opdivo (nivolumab); Bristol-Myers Squibb;
For the treatment of unresectable or metastatic melanoma, Approved December 2014
Orbactiv (oritavancin); The Medicines Company;
For the treatment of acute bacterial skin and skin structure infections, Approved August 2014
Otezla (apremilast); Celgene;
For the treatment of moderate to severe plaque psoriasis, Approved September 2014
Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals;
For the treatment of acute bacterial skin and skin structure infections, Approved June 2014
Soolantra (ivermectin) cream, 1%; Galderma Labs;
For the treatment of inflammatory lesions of rosacea, Approved December 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
Eylea (aflibercept); Regeneron Pharmaceuticals;
For the treatment of diabetic macular edema, Approved July 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
Signifor LAR (pasireotide); Novartis;
For the treatment of acromegaly, Approved December 2014
Tanzeum (albiglutide); GlaxoSmithKline;
For the treatment of type II diabetes mellitus, Approved April 2014
Trulicity (dulaglutide); Eli Lilly;
To improve glycemic control in type II diabetics, Approved September 2014
Vogelxo (testosterone) gel; Upsher-Smith;
For males with a deficiency or absence of endogenous testosterone, Approved June 2014
Xigduo XR (dapagliflozin + metformin hydrochloride); AstraZeneca;
For glycemic control in adults with type II diabetes, Approved October 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
Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline;
For the treatment of asthma, Approved August 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
Contrave (naltrexone HCl and bupropion HCl) ; Takeda Pharmaceuticals U.S.A.;
For chronic weight management , Approved September 2014
Dalvance (dalbavancin); Durata Therapeutics;
For the treatment of acute bacterial skin and skin structure infections, Approved May 2014
Dyloject (diclofenac sodium) Injection; Hospira;
For the management of mild, moderate or severe pain, Approved December 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
Otezla (apremilast); Celgene;
For the treatment of moderate to severe plaque psoriasis, Approved September 2014
Plegridy (peginterferon beta-1a); Biogen IDEC.;
For the treatment of relapsing multiple sclerosis, Approved August 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
Rapivab (peramivir injection); Biocryst;
For the treatment of acute uncomplicated influenza in adults, Approved December 2014
Saxenda (liraglutide [rDNA origin] injection); Novo Nordisk;
For chronic weight management, Approved December 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
Trulicity (dulaglutide); Eli Lilly;
To improve glycemic control in type II diabetics, Approved September 2014
Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt Pharmaceuticals;
For the management of acute pain, Approved March 2014
Xtoro (finafloxacin otic suspension) 0.3%; Alcon;
For the treatment of acute otitis externa, Approved December 2014
Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals;
For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014
Gastroenterology
Akynzeo (netupitant and palonosetron); Helsinn;
For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014
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
Movantik (naloxegol); AstraZeneca;
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain, Approved September 2014
Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals;
For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014
Genetic Disease
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec;
For the treatment of hemophilia B, Approved March 2014
Cerdelga (eliglustat); Genzyme;
For the treatment of certain adult patients with Gaucher disease type 1, Approved August 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
Blincyto (blinatumomab); Amgen;
For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, Approved December 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 and small lymphocytic lymphoma, Approved February 2014
Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence]; Baxter;
For the treatment of acquired hemophilia A, Approved October 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
HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]; Baxter;
For the treatment of Primary Immunodeficiency, Approved September 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
Otezla (apremilast); Celgene;
For the treatment of moderate to severe plaque psoriasis, Approved September 2014
Plegridy (peginterferon beta-1a); Biogen IDEC.;
For the treatment of relapsing multiple sclerosis, Approved August 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
Triumeq (abacavir, dolutegravir, and lamivudine); ViiV HealthCare;
For the treatment of HIV-1, Approved August 2014
Infections and Infectious Diseases
Dalvance (dalbavancin); Durata Therapeutics;
For the treatment of acute bacterial skin and skin structure infections, Approved May 2014
Harvoni (ledipasvir and sofosbuvir); Gilead;
For the treatment of hepatitis C, Approved October 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
Rapivab (peramivir injection); Biocryst;
For the treatment of acute uncomplicated influenza in adults, Approved December 2014
Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals;
For the treatment of acute bacterial skin and skin structure infections, Approved June 2014
Triumeq (abacavir, dolutegravir, and lamivudine); ViiV HealthCare;
For the treatment of HIV-1, Approved August 2014
Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Abbvie;
For the treatment of genotype 1 chronic hepatitis C virus, Approved December 2014
Xtoro (finafloxacin otic suspension) 0.3%; Alcon;
For the treatment of acute otitis externa, Approved December 2014
Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals;
For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014
Internal Medicine
Cerdelga (eliglustat); Genzyme;
For the treatment of certain adult patients with Gaucher disease type 1, Approved August 2014
Musculoskeletal
Lemtrada (alemtuzumab); Genzyme;
For the treatment of relapsing multiple sclerosis, Approved November 2014
Otezla (apremilast); Celgene;
For the treatment of adults with active psoriatic arthritis, Approved March 2014
Plegridy (peginterferon beta-1a); Biogen IDEC.;
For the treatment of relapsing multiple sclerosis, Approved August 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
Nephrology
Auryxia (Ferric citrate); Keryx Biopharma;
For the treatment of hyperphosphatemia in patients with chronic kidney disease, Approved September 2014
Harvoni (ledipasvir and sofosbuvir); Gilead;
For the treatment of hepatitis C, Approved October 2014
Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Abbvie;
For the treatment of genotype 1 chronic hepatitis C virus, Approved December 2014
Neurology
Belsomra (suvorexant); Merck;
For the treatment of insomnia, Approved August 2014
Dyloject (diclofenac sodium) Injection; Hospira;
For the management of mild, moderate or severe pain, Approved December 2014
Hetlioz (tasimelteon); Vanda Pharmaceuticals;
For the treatment of non-24-hour sleep-wake disorder in the totally blind, January 2014
Lemtrada (alemtuzumab); Genzyme;
For the treatment of relapsing multiple sclerosis, Approved November 2014
Movantik (naloxegol); AstraZeneca;
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain, Approved September 2014
Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride); Forest Laboratories;
For the treatment of moderate to severe dementia of the Alzheimer's type, Approved December 2014
Northera (droxidopa); Chelsea Therapeutics;
For the treatment of neurogenic orthostatic hypotension, Approved February 2014
Plegridy (peginterferon beta-1a); Biogen IDEC.;
For the treatment of relapsing multiple sclerosis, Approved August 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
Contrave (naltrexone HCl and bupropion HCl) ; Takeda Pharmaceuticals U.S.A.;
For chronic weight management , Approved September 2014
Jardiance (empagliflozin) ; Boehringer Ingelheim;
For the treatment of type II diabetes, Approved August 2014
Saxenda (liraglutide [rDNA origin] injection); Novo Nordisk;
For chronic weight management, Approved December 2014
Tanzeum (albiglutide); GlaxoSmithKline;
For the treatment of type II diabetes mellitus, Approved April 2014
Trulicity (dulaglutide); Eli Lilly;
To improve glycemic control in type II diabetics, Approved September 2014
Obstetrics/Gynecology (Women’s Health)
Avastin (bevacizumab); Genentech;
For the treatment of persistent, recurrent, or metastatic cervical cancer, Approved August 2014
Avastin (bevacizumab); Genentech;
For the treatment of stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved November 2014
Lynparza (olaparib); AstraZeneca;
For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014
Metronidazole 1.3% Vaginal Gel; Actavis, Inc.;
For the treatment of bacterial vaginosis, Approved April 2014
Oncology
Akynzeo (netupitant and palonosetron); Helsinn;
For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014
Avastin (bevacizumab); Genentech;
For the treatment of stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved November 2014
Avastin (bevacizumab); Genentech;
For the treatment of persistent, recurrent, or metastatic cervical cancer, Approved August 2014
Beleodaq (belinostat); Spectrum Pharmaceuticals;
For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014
Blincyto (blinatumomab); Amgen;
For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014
Cyramza (ramucirumab); Eli Lilly;
For the treatment of gastric cancer, Approved April 2014
Imbruvica (ibrutinib); Pharmacyclics;
For the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma, Approved February 2014
Keytruda (pembrolizumab); Merck;
For the treatment of unresectable or metastatic melanoma, Approved September 2014
Lynparza (olaparib); AstraZeneca;
For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014
Opdivo (nivolumab); Bristol-Myers Squibb;
For the treatment of unresectable or metastatic melanoma, Approved December 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
Eylea (aflibercept); Regeneron Pharmaceuticals;
For the treatment of diabetic macular edema, Approved July 2014
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
Xtoro (finafloxacin otic suspension) 0.3%; Alcon;
For the treatment of acute otitis externa, Approved December 2014
Pediatrics/Neonatology
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec;
For the treatment of hemophilia B, Approved March 2014
Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline;
For the treatment of asthma, Approved August 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
Akynzeo (netupitant and palonosetron); Helsinn;
For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014
Bunavail (buprenorphine and naloxone); BioDelivery Sciences;
For the maintenance treatment of opioid dependence, Approved June 2014
Movantik (naloxegol); AstraZeneca;
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain, Approved September 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
Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline;
For the treatment of asthma, Approved August 2014
Esbriet (pirfenidone); InterMune;
For the treatment of idiopathic pulmonary fibrosis , Approved October 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
Ofev (nintedanib); Boehringer Ingelheim;
For the treatment of idiopathic pulmonary fibrosis , Approved October 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
Urology
Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals;
For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014
The criteria for CenterWatch's FDA-Approved Drugs follow the definitions established by the Tufts Center for the Study of Drug Development and the FDA's definitions of a new drug approval or a new molecular entity.
Database inclusions:
New Molecular Entities (NME) is defined by the FDA as a medication containing an active substance that has never before been approved for marketing in any form in the United States. The database also includes some recombinant proteins and biologics that were approved by the FDA's Center for Drug Evaluation and Research (CDER).
Database exclusions:
Diagnostic agents, generics, over-the-counter products, medical devices, and biologic compounds not approved by CDER. Other exclusions are new dosages and new administrations of previously-approved compounds.
