FDA Calendar

Advisory Committee and PDUFA Date Activity

Generic Name Trade NameOriginatorIndicationDate
palbociclibIbrancePfizer Inc.advanced breast cancer04/13/2015 PDUFA
LENVATINIB LenvimaEisai Co Ltdprogressive radioiodine-refractory differentiated thyroid cancer04/14/2015 PDUFA
Cangrelor injectionThe Medicines Co.reducing thrombotic cardiovascular events including stent thrombosis04/15/2015 Adcomm
ibrutinibIMBRUVICAPharmacyclics Inc.Waldenstrom's macroglobulinemia04/17/2015 PDUFA
Talimogene Laherparepvec T-VECAmgen Inc.metastatic melanoma04/29/2015 Adcomm
TuzistraVernalis plccough and cold04/30/2015 PDUFA
Fluticasone furoate/vilanterolBREO ELLIPTA THERAVANCE, INC.asthma in patients aged 12 years and older04/30/2015 PDUFA
sodium deoxycholateATX-101KYTHERA BIOPHARMACEUTICALS INCmoderate to severe submental fullness05/13/2015 PDUFA
rifaximinXIFAXAN 550 mg tablets Salix Pharmaceuticals Ltdirritable bowel syndrome with diarrhea05/27/2015 PDUFA
rifaximinXIFAXAN Salix Pharmaceuticals Ltdirritable bowel syndrome with diarrhea or IBS-D05/27/2015 PDUFA
nivolumabOpdivoBristol-Myers Squibb Co.advanced squamous non-small cell lung cancer after prior therapy06/22/2015 PDUFA
Lumacaftor / Ivacaftor comboKalydecoVertex Pharmaceuticals Inc.CF ages 12 and older who have two copies of the F508del mutation07/05/2015 PDUFA