Drugs Approved by FDA in 2015

31 Aug 2016

 CLASSIFICATION OF DRUGS ACCORDING TO SYSTEM-2015

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

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

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.