2017 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
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Find out more about the types of drugs included in this listing.
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
Aliqopa (copanlisib); Bayer;
For the treatment of follicular lymphoma , Approved September 2017
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
Kymriah (tisagenlecleucel); Novartis;
For the treatment of refractory B-cell precursor acute lymphoblastic leukemia , 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
Actemra (tocilizumab) injection; Genentech;
For the treatment of CAR T cell-induced severe or life-threatening cytokine release syndrome, Approved September 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
Benznidazole; Chemo Group;
For the treatment of Chagas disease , Approved August 2017
KedRab [Rabies Immune Globulin (Human)]; Kedrion Biopharma ;
For the post-exposure prophylaxis of rabies infection, Approved August 2017
Mavyret (glecaprevir and pibrentasvir) ; AbbVie;
For the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6, Approved August 2017
Solosec (secnidazole) ; Symbiomix Therapeutics;
For the treatment of bacterial vaginosis , Approved September 2017
Vabomere (meropenem and vaborbactam); The Medicines Company;
For the treatment of complicated urinary tract infections , Approved August 2017
Internal Medicine
Duzallo (lesinurad and allopurinol) ; Ardea Biosciences;
For the treatment of hyperuricemia associated with gout , Approved August 2017
Musculoskeletal
Brineura (cerliponase alfa); BioMarin;
For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017
Duzallo (lesinurad and allopurinol) ; Ardea Biosciences;
For the treatment of hyperuricemia associated with gout , Approved August 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 and tardive dyskinesia , Initial approval April 2017
Brineura (cerliponase alfa); BioMarin;
For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017
Gocovri (amantadine) ; Adamas Pharmaceuticals;
For the treatment of Parkinson's disease dyskinesia, Approved August 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
Solosec (secnidazole) ; Symbiomix Therapeutics;
For the treatment of bacterial vaginosis , Approved September 2017
Tymlos (abaloparatide) ; Radius Health;
For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved April 2017
Verzenio (abemaciclib); Eli Lilly;
For the treatment of HR+, HER2- breast cancer, Approved September 2017
Zejula (niraparib); Tesaro;
For the treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved March 2017
Oncology
Aliqopa (copanlisib); Bayer;
For the treatment of follicular lymphoma , Approved September 2017
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
Kymriah (tisagenlecleucel); Novartis;
For the treatment of refractory B-cell precursor acute lymphoblastic leukemia , Approved August 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
Verzenio (abemaciclib); Eli Lilly;
For the treatment of HR+, HER2- breast cancer, Approved September 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
Pharmacology/Toxicology
Actemra (tocilizumab) injection; Genentech;
For the treatment of CAR T cell-induced severe or life-threatening cytokine release syndrome, Approved September 2017
Gocovri (amantadine) ; Adamas Pharmaceuticals;
For the treatment of Parkinson's disease dyskinesia, Approved August 2017
Rheumatology
Duzallo (lesinurad and allopurinol) ; Ardea Biosciences;
For the treatment of hyperuricemia associated with gout , Approved August 2017
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
Vabomere (meropenem and vaborbactam); The Medicines Company;
For the treatment of complicated urinary tract infections , Approved August 2017
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.
