New Drug Approvals FDA 2013

8/22/2019 New Drug Approvals FDA 2013

1/7

http://www.centerwatch.com/drug-information/fda-approvals/

FDA Approved Drugs

The following database contains a listing of drugs approved by the Foodand 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.

2013

Cardiology/Vascular Diseases

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial

hypercholesterolemia, Approved January 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved

May 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of

ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Dermatology

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes

labialis in adults, Approved April 2013

Devices

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For

the treatment of chronic obstructive pulmonary disease, Approved May 2013

Endocrinology

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes

mellitus, Approved April 2013

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January

2013
http://www.centerwatch.com/drug-information/fda-approvals/http://www.centerwatch.com/drug-information/fda-approvals/http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1265http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1265http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1258http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1258http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1258http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1265http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250http://www.centerwatch.com/drug-information/fda-approvals/


2/7

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal

atrophy due to menopause, Approved March 2013

Family Medicine

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic

Arthritis, Approved May 2013



Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against

influenza virus subtypes A and type B, Approved January 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis,

Approved May 2013

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes

mellitus, Approved April 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved

May 2013


2013



Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For

the prevention of conception, Approved April 2013



Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis,

Approved March 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Gastroenterology
http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1258http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1258http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1265http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1265http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1259http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1259http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1248http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1248http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1248http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1259http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1265http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1258http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256


3/7

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved

February 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Genetic DiseaseKineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated

Periodic Syndromes, Approved January 2013



Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and

adults with urea cycle disorders, Approved February 2013

Healthy Volunteers



Hematology

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K

antagonist therapy-induced coagulation factor deficiency, Approved May 2013



Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple

myeloma, Approved February 2013



ImmunologyFlublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against


Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1255http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1255http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1248http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1248http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1253http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1253http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1253http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1248http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1255


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Approved March 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure

prophylaxis of varicella zoster (chickenpox), Approved January 2013

Infections and Infectious Diseases







Musculoskeletal




Approved May 2013


Approved March 2013

Nephrology

Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals; For the management of

nephropathic cystinosis, Approved May 2013

Neurology


http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1266http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1266http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1262http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1266http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1257http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1260


5/7

Nutrition and Weight Loss


2013

Obstetrics/Gynecology (Womens Health)

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive

metastatic breast cancer, Approved February 2013



Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For

the prevention of conception, Approved April 2013

Oncology

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive

metastatic breast cancer, Approved February 2013

Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple

myeloma, Approved February 2013

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved

February 2013

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of

prostate cancer with bone metastases, Approved May 2013

Pediatrics/Neonatology




Approved May 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1254http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1254http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1259http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1259http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1254http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1254http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1253http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1253http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1255http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1255http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1261http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1261http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1246http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1261http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1255http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1253http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1254http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1259http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1256http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1254http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1251


6/7





Pharmacology/Toxicology

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K


Pulmonary/Respiratory Diseases



Rheumatology




Approved May 2013

Trauma (Emergency, Injury, Surgery)Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K


Urology

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of

prostate cancer with bone metastases, Approved May 2013

VaccinesFlublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against



http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1261http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1261http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1247http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1249http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1261http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1263http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1268http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1264http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1267http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1252http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1250


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Documents

New Drug Approvals FDA 2013