New 2017 FDA Approved Drugs

Cardiology/Vascular Diseases

Bevyxxa (betrixaban); Portola Pharmaceuticals; For the the prophylaxis of venous thromboembolism, Approved June 2017

Dermatology

Bavencio (avelumab) ; EMD Serono/Pfizer; For the treatment of Merkel cell carcinoma , Approved March 2017

Baxdela (delafloxacin) tablets and injection; Melinta Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved June 2017

Dupixent (dupilumab); Regeneron Pharmaceuticals; For the treatment of atopic dermatitis, Approved March 2017

Rhofade (oxymetazoline hydrochloride); Allergan; For the treatment of facial erythema associated with rosacea, Approved January 2017

Siliq (brodalumab); Valeant Pharmaceuticals; For the treatment of plaque psoriasis , Approved February 2017

Tremfya (guselkumab); Janssen Biotech; For the treatment of moderate-to-severe plaque psoriasis, Approved July 2017

Endocrinology

Parsabiv (etelcalcetide); Amgen; For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Approved February 2017

Qtern (dapagliflozin and saxagliptin) ; AstraZeneca; For the treatment of inadequately controlled type II diabetes , Approved February 2017

Family Medicine

Qtern (dapagliflozin and saxagliptin) ; AstraZeneca; For the treatment of inadequately controlled type II diabetes , Approved February 2017

Trulance (plecanatide); Synergy Pharmaceuticals; For the treatment of adults with chronic idiopathic constipation, Approved January 2017

Gastroenterology

Symproic (naldemedine); Shionogi; For the treatment of opioid-induced constipation, Approved March 2017

Trulance (plecanatide); Synergy Pharmaceuticals; For the treatment of adults with chronic idiopathic constipation, Approved January 2017

Xermelo (telotristat ethyl); Lexicon Pharmaceuticals; For the treatment of carcinoid syndrome diarrhea, Approved February 2017

Genetic Disease

Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) ; CSL Behring; For the routine prophylaxis to prevent Hereditary Angioedema attacks, Approved June 2017

Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017

Hematology

Besponsa (inotuzumab ozogamicin); Pfizer; For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, Approved August 2017

Endari (L-glutamine oral powder); Emmaus Life Sciences; For the treatment of sickle cell disease , Approved July 2017

IDHIFA (enasidenib); Celgene; For the treatment of relapsed or refractory acute myeloid leukemia with IDH2 mutation , Approved August 2017

Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) ; Novo Nordisk; For the treatment of hemophilia B, Approved June 2017

Rydapt (midostaurin); Novartis; For the treatment of FLT3 positive acute myeloid leukemia and mastocytosis , Approved April 2017

Vyxeos (daunorubicin and cytarabine) ; Jazz Pharma; For the treatment of newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes, Approved August 2017

Hepatology (Liver, Pancreatic, Gall Bladder)

Mavyret (glecaprevir and pibrentasvir) ; AbbVie; For the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6, Approved August 2017

Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) ; Gilead; For the treatment of hepatitis C, Approved July 2017

Immunology

Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) ; CSL Behring; For the routine prophylaxis to prevent Hereditary Angioedema attacks, Approved June 2017

Ocrevus (ocrelizumab); Genentech; For the treatment of multiple sclerosis, Approved March 2017

Tremfya (guselkumab); Janssen Biotech; For the treatment of moderate-to-severe plaque psoriasis, Approved July 2017

Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) ; Gilead; For the treatment of hepatitis C, Approved July 2017

Zerviate (cetirizine ophthalmic solution 0.24%); NicOx; For the treatment of ocular itching associated with allergic conjunctivitis, Approved May 2017

Infections and Infectious Diseases

Baxdela (delafloxacin) tablets and injection; Melinta Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved June 2017

Mavyret (glecaprevir and pibrentasvir) ; AbbVie; For the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6, Approved August 2017

Musculoskeletal

Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017

Emflaza (deflazacort); Marathon Pharmaceuticals; For the treatment of Duchenne muscular dystrophy, Approved February 2017

Kevzara (sarilumab); Sanofi ; For the treatment of active rheumatoid arthritis, Approved May 2017

Ocrevus (ocrelizumab); Genentech; For the treatment of multiple sclerosis, Approved March 2017

Tymlos (abaloparatide) ; Radius Health; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved April 2017

Nephrology

Parsabiv (etelcalcetide); Amgen; For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Approved February 2017

Neurology

Austedo (deutetrabenazine) ; Teva Pharmaceuticals; For the treatment of chorea associated with Huntington’s disease, Approved April 2017

Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017

Ingrezza (valbenazine); Neurocrine Biosciences; For the treatment of tardive dyskinesia, Approved April 2017

Radicava (edaravone); Mitsubishi Tanabe Pharma; For the treatment of amyotrophic lateral sclerosis , Approved May 2017

Xadago (safinamide); Newron Pharmaceuticals; For the treatment of Parkinson’s disease, Approved March 2017

Obstetrics/Gynecology (Women’s Health)

Kisqali (ribociclib); Novartis; For the treatment of breast cancer, Approved March 2017

Tymlos (abaloparatide) ; Radius Health; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved April 2017

Zejula (niraparib); Tesaro; For the treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved March 2017

Oncology

Alunbrig (brigatinib); Ariad Pharmaceuticals; For the treatment of advanced ALK-positive metastatic non-small cell lung cancer, Approved April 2017

Bavencio (avelumab) ; EMD Serono/Pfizer; For the treatment of Merkel cell carcinoma , Approved March 2017

Besponsa (inotuzumab ozogamicin); Pfizer; For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, Approved August 2017

IDHIFA (enasidenib); Celgene; For the treatment of relapsed or refractory acute myeloid leukemia with IDH2 mutation , Approved August 2017

Imfinzi (durvalumab); AstraZeneca; For the treatment of advanced or metastatic urothelial carcinoma, Approved May 2017

Kisqali (ribociclib); Novartis; For the treatment of breast cancer, Approved March 2017

Nerlynx (neratinib); Puma Biotech; For the treatment of HER2 breast cancer, Approved July 2017

Rydapt (midostaurin); Novartis; For the treatment of FLT3 positive acute myeloid leukemia and mastocytosis , Approved April 2017

Vyxeos (daunorubicin and cytarabine) ; Jazz Pharma; For the treatment of newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes, Approved August 2017

Xermelo (telotristat ethyl); Lexicon Pharmaceuticals; For the treatment of carcinoid syndrome diarrhea, Approved February 2017

Zejula (niraparib); Tesaro; For the treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved March 2017

Ophthalmology

Zerviate (cetirizine ophthalmic solution 0.24%); NicOx; For the treatment of ocular itching associated with allergic conjunctivitis, Approved May 2017

Pediatrics/Neonatology

Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017

Emflaza (deflazacort); Marathon Pharmaceuticals; For the treatment of Duchenne muscular dystrophy, Approved February 2017

Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) ; Novo Nordisk; For the treatment of hemophilia B, Approved June 2017

Rheumatology

Kevzara (sarilumab); Sanofi ; For the treatment of active rheumatoid arthritis, Approved May 2017

Urology

Imfinzi (durvalumab); AstraZeneca; For the treatment of advanced or metastatic urothelial carcinoma, Approved May 2017