FDA Calendar

Advisory Committee and PDUFA Date Activity

Generic Name Trade NameOriginatorIndicationDate
bupivacaineEXPARELPacira Pharmaceuticals, Inc.femoral nerve block for total knee arthroplasty03/05/2015 PDUFA
ATX-101sodium deoxycholateKYTHERA BIOPHARMACEUTICALS INCmoderate to severe submental fullness03/09/2015 Adcomm
IvacaftorKalydecoVertex Pharmaceuticals Inc.children with CF ages 2 to 5 who have G551D or one of the 8 addnl.gating mutations03/17/2015 PDUFA
Sugammadex sodium injectionBridionMerck & Co Inc.reversal of neuromuscular blockade induced by rocuronium or vecuronium03/18/2015 Adcomm
Fluticasone furoate/vilanterolBREO ELLIPTA THERAVANCE, INC.asthma in patients aged 12 years and older03/19/2015 Adcomm
afliberceptEYLEARegeneron Pharmaceuticalsdiabetic retinopathy in patients with DME03/30/2015 PDUFA
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