FDA Calendar

Advisory Committee and PDUFA Date Activity

Generic Name Trade NameOriginatorIndicationDate
ferric pyrophosphate citrateTrifericRockwell Medical Technologies Inciron loss in CKD patients receiving hemodialysis01/24/2015 PDUFA
recombinant human parathyroid hormoneNatparaNPS Pharmaceuticals IncHypo parathyroidism01/24/2015 PDUFA
hydrocodoneModified formulation of Zohydro ER Zogenix, Inc.designed to have abuse deterrent properties01/30/2015 PDUFA
fibrinogen; thrombinRAPLIXAThe Medicines Co.hemostasis during surgery01/31/2015 PDUFA
ranibizumabLucentisRoche Holding AGdiabetic retinopathy02/06/2015 PDUFA
levonorgestrelLevosertActavis Plc.for use by women to prevent pregnancy02/28/2015 PDUFA
rifaximinXIFAXAN 550 mg tablets Salix Pharmaceuticals Ltdirritable bowel syndrome with diarrhea02/28/2015 PDUFA
bupivacaineEXPARELPacira Pharmaceuticals, Inc.femoral nerve block for total knee arthroplasty03/05/2015 PDUFA
afliberceptEYLEARegeneron Pharmaceuticalsdiabetic retinopathy in patients with DME03/30/2015 PDUFA