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2015 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

Corlanor (ivabradine); Amgen; For the treatment of chronic heart failure, Approved April 2015

Entresto (sacubitril and valsartan); Novartis; For the treatment of chronic heart failure, Approved July 2015

Kanuma (sebelipase alfa); Alexion; For the treatment of Lysosomal Acid Lipase (LAL) deficiency, Approved December 2015

Kengreal (cangrelor) ; The Medicines Company; For reducing periprocedural thrombotic events, Approved June 2015

Praluent (alirocumab); Sanofi Aventis; For the treatment of heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease, Approved July 2015

Prestalia (perindopril arginine and amlodipine besylate); Symplmed Pharmaceuticals; For the treatment of hypertension, Approved January 2015

Repatha (evolocumab) ; Amgen; For the treatment of high cholesterol, Approved August 2015

Savaysa (edoxaban); Daiichi Sankyo; For the treatment of deep vein thrombosis, pulmonary embolism and risk of stroke and embolism due to atrial fibrillation, Approved January 2015

Uptravi (selexipag); Actelion Pharmaceuticals; For the treatment of pulmonary arterial hypertension, Approved December 2015

Dermatology

Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015

Cotellic (cobimetinib) ; Genentech; For the treatment of BRAF V600E or V600K melanoma, Approved November 2015

Enstilar (calcipotriene and betamethasone dipropionate); LEO Pharmaceuticals; For the treatment of psoriasis, Approved October 2015

Imlygic (talimogene laherparepvec) ; Amgen; For the treatment of unresectable recurrent melanoma, Approved October 2015

Kybella (deoxycholic acid); Kythera Biopharma; For the treatment of submental fat, Approved April 2015

Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015

Endocrinology

Addyi (flibanserin); Sprout Pharmaceuticals; For the treatment of premenopausal women with generalized hypoactive sexual desire disorder, Approved August 2015

Natpara (parathyroid hormone) ; NPS Pharmaceuticals; For the control hypocalcemia in patients with hypoparathyroidism, Approved January 2015

Synjardy (empagliflozin and metformin hydrochloride) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2015

Tresiba (insulin degludec injection); Novo Nordisk; For glycemic control in adults with diabetes mellitus, Approved September 2015

Family Medicine

Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015

Cresemba (isavuconazonium sulfate) ; Astellas; For the treatment of invasive aspergillosis and invasive mucormycosis, Approved March 2015

Enstilar (calcipotriene and betamethasone dipropionate); LEO Pharmaceuticals; For the treatment of psoriasis, Approved October 2015

Kybella (deoxycholic acid); Kythera Biopharma; For the treatment of submental fat, Approved April 2015

Otiprio (ciprofloxacin otic suspension); Otonomy; For the treatment of pediatrics with bilateral otitis media with effusion undergoing tympanostomy tube placement, Approved December 2015

Savaysa (edoxaban); Daiichi Sankyo; For the treatment of deep vein thrombosis, pulmonary embolism and risk of stroke and embolism due to atrial fibrillation, Approved January 2015

Viberzi (eluxadoline); Actavis; For the treatment of irritable bowel syndrome with diarrhea, Approved May 2015

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of irritable bowel syndrome with diarrhea , Approved May 2015

Gastroenterology

Avycaz (ceftazidime-avibactam); Actavis; For the treatment of complicated intra-abdominal and urinary tract infections, Approved February 2015

Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015

Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015

Onivyde (irinotecan liposome injection); Merrimack; For the treatment of metastatic pancreatic cancer following gemcitabine-based therapy, Approved October 2015

Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapy, Approved September 2015

Viberzi (eluxadoline); Actavis; For the treatment of irritable bowel syndrome with diarrhea, Approved May 2015

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of irritable bowel syndrome with diarrhea , Approved May 2015

Genetic Disease

Kanuma (sebelipase alfa); Alexion; For the treatment of Lysosomal Acid Lipase (LAL) deficiency, Approved December 2015

Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015

Xuriden (uridine triacetate); Wellstat Therapeutics; For the treatment of hereditary orotic aciduria, Approved September 2015

Hematology

Darzalex (daratumumab); Janssen Biotech; For the treatment of multiple myeloma, Approved November 2015

Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015

Natpara (parathyroid hormone) ; NPS Pharmaceuticals; For the control hypocalcemia in patients with hypoparathyroidism, Approved January 2015

Nuwiq (recombinant Factor VIII); Octapharma; For the prophylaxis and treatment of hemophilia A, Approved September 2015

Praxbind (idarucizumab); Boehringer Ingelheim; For the reversal of the anticoagulant effects of dabigatran, Approved October 2015

Veltassa (patiromer); Relypsa; For the treatment of hyperkalemia, Approved October 2015

Hepatology (Liver, Pancreatic, Gall Bladder)

Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015

Daklinza (daclatasvir) ; Bristol-Myers Squibb; For the treatment of chronic HCV genotype 3, Approved July 2015

Technivie, (ombitasvir, paritaprevir and ritonavir); Abbvie; For the treatment of chronic HCV genotype 4, Approved July 2015

Immunology

Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015

Envarsus XR (tacrolimus extended-release); Veloxis; For the prophylaxis of organ rejection in kidney transplant patients , Approved July 2015

Evotaz (atazanavir and cobicistat) ; Bristol-Myers Squibb; For the treatment of HIV-1 infection, Approved January 2015

Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 infection, Approved November 2015

Prezcobix (darunavir and cobicistat); Janssen; For the treatment of HIV-1 infection, Approved January 2015

Infections and Infectious Diseases

Avycaz (ceftazidime-avibactam); Actavis; For the treatment of complicated intra-abdominal and urinary tract infections, Approved February 2015

Bexsero (Meningococcal Group B Vaccine); Novartis; For the treatment of invasive meningococcal disease caused by serogroup B, Approved January 2015

Cresemba (isavuconazonium sulfate) ; Astellas; For the treatment of invasive aspergillosis and invasive mucormycosis, Approved March 2015

Daklinza (daclatasvir) ; Bristol-Myers Squibb; For the treatment of chronic HCV genotype 3, Approved July 2015

Evotaz (atazanavir and cobicistat) ; Bristol-Myers Squibb; For the treatment of HIV-1 infection, Approved January 2015

Fluad (trivalent influenza vaccine); Seqirus; For the prevention of influenza A and B, Approved November 2015

Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 infection, Approved November 2015

Prezcobix (darunavir and cobicistat); Janssen; For the treatment of HIV-1 infection, Approved January 2015

Technivie, (ombitasvir, paritaprevir and ritonavir); Abbvie; For the treatment of chronic HCV genotype 4, Approved July 2015

Musculoskeletal

Vivlodex (meloxicam) ; Iroko Pharmaceuticals; For the management of osteoarthritis pain, Approved October 2015

Nephrology

Envarsus XR (tacrolimus extended-release); Veloxis; For the prophylaxis of organ rejection in kidney transplant patients , Approved July 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of advanced renal cell carcinoma, Approved November 2015

Zurampic (lesinurad); AstraZeneca; For the treatment of hyperuricemia associated with gout , Approved December 2015

Neurology

Aristada (aripiprazole lauroxil) extended-release injectable; Alkermes; For the treatment of schizophrenia, Approved October 2015

Belbuca (buprenorphine) ; Endo Pharmaceuticals; For the management of severe pain, Approved October 2015

Duopa (carbidopa and levodopa) enteral suspension ; Abbvie; For the treatment of motor fluctuations in patients with advanced Parkinson's disease, Approved January 2015

Rytary (carbidopa and levodopa) extended-release capsules; Impax Labs; For the treatment of Parkinson's disease, Approved January 2015

Vivlodex (meloxicam) ; Iroko Pharmaceuticals; For the management of osteoarthritis pain, Approved October 2015

Vraylar (cariprazine); Allergan; For the treatment of schizophrenia and bipolar disorder, Approved September 2015

Obstetrics/Gynecology (Women’s Health)

Addyi (flibanserin); Sprout Pharmaceuticals; For the treatment of premenopausal women with generalized hypoactive sexual desire disorder, Approved August 2015

Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015

Oncology

Alecensa (alectinib); Roche; For the treatment of ALK-positive, metastatic non-small cell lung cancer , Approved December 2015

Cotellic (cobimetinib) ; Genentech; For the treatment of BRAF V600E or V600K melanoma, Approved November 2015

Darzalex (daratumumab); Janssen Biotech; For the treatment of multiple myeloma, Approved November 2015

Empliciti (elotuzumab); Bristol-Myers Squibb; For the treatment of patients with multiple myeloma who have received prior therapies, Approved November 2015

Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015

Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015

Imlygic (talimogene laherparepvec) ; Amgen; For the treatment of unresectable recurrent melanoma, Approved October 2015

Keytruda (pembrolizumab); Merck; For the treatment of PD-L1 positive advanced non-small cell lung cancer, Approved October 2015

Lenvima (lenvatinib); Eisai; For the treatment of thyroid cancer, Approved February 2015

Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015

Ninlaro (ixazomib); Millennium Pharmaceuticals; For the treatment of multiple myeloma, Approved November 2015

Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015

Onivyde (irinotecan liposome injection); Merrimack; For the treatment of metastatic pancreatic cancer following gemcitabine-based therapy, Approved October 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of advanced renal cell carcinoma, Approved November 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015

Portrazza (necitumumab) ; Eli Lilly; For the treatment of metastatic squamous non-small cell lung cancer, Approved November 2015

Tagrisso (osimertinib); AstraZeneca; For the treatment of EGFR T790M mutation positive non-small cell lung cancer , Approved November 2015

Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015

Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapy, Approved September 2015

Vistogard (uridine triacetate); Wellstat Therapeutics; For the emergency treatment of patients with a fluorouracil or capecitabine overdose, Approved December 2015

Yondelis (trabectedin); Janssen; For the treatment of liposarcoma or leiomyosarcoma, Approved October 2015

Orthopedics/Orthopedic Surgery

Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015

Otolaryngology (Ear, Nose, Throat)

Otiprio (ciprofloxacin otic suspension); Otonomy; For the treatment of pediatrics with bilateral otitis media with effusion undergoing tympanostomy tube placement, Approved December 2015

Pediatrics/Neonatology

Bexsero (Meningococcal Group B Vaccine); Novartis; For the treatment of invasive meningococcal disease caused by serogroup B, Approved January 2015

Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015

Kanuma (sebelipase alfa); Alexion; For the treatment of Lysosomal Acid Lipase (LAL) deficiency, Approved December 2015

Orkambi (lumacaftor and ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis, Approved July 2015

Otiprio (ciprofloxacin otic suspension); Otonomy; For the treatment of pediatrics with bilateral otitis media with effusion undergoing tympanostomy tube placement, Approved December 2015

Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015

Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015

Pharmacology/Toxicology

Bridion (sugammadex); Merck; For the reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery, Approved December 2015

Psychiatry/Psychology

Aristada (aripiprazole lauroxil) extended-release injectable; Alkermes; For the treatment of schizophrenia, Approved October 2015

Rexulti (brexpiprazole); Otsuka; For the treatment of depression and schizophrenia, Approved July 2015

Vraylar (cariprazine); Allergan; For the treatment of schizophrenia and bipolar disorder, Approved September 2015

Pulmonary/Respiratory Diseases

Alecensa (alectinib); Roche; For the treatment of ALK-positive, metastatic non-small cell lung cancer , Approved December 2015

Keytruda (pembrolizumab); Merck; For the treatment of PD-L1 positive advanced non-small cell lung cancer, Approved October 2015

Nucala (mepolizumab); GlaxoSmithKline; For the treatment of severe asthma with an eosinophilic phenotype, Approved November 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015

Orkambi (lumacaftor and ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis, Approved July 2015

Portrazza (necitumumab) ; Eli Lilly; For the treatment of metastatic squamous non-small cell lung cancer, Approved November 2015

Stiolto Respimat (tiotropium bromide and olodaterol) ; Boehringer Ingelheim; For the maintenance of chronic obstructive pulmonary disease, Approved May 2015

Tagrisso (osimertinib); AstraZeneca; For the treatment of EGFR T790M mutation positive non-small cell lung cancer , Approved November 2015

Utibron Neohaler (indacaterol and glycopyrrolate); Novartis; For the long term, maintenance treatment of airflow obstruction in patients with COPD, Approved October 2015

Urology

Avycaz (ceftazidime-avibactam); Actavis; For the treatment of complicated intra-abdominal and urinary tract infections, Approved February 2015

Xuriden (uridine triacetate); Wellstat Therapeutics; For the treatment of hereditary orotic aciduria, Approved September 2015

Vaccines

Bexsero (Meningococcal Group B Vaccine); Novartis; For the treatment of invasive meningococcal disease caused by serogroup B, Approved January 2015

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