FDA Calendar

Advisory Committee and PDUFA Date Activity

Generic Name Trade NameOriginatorIndicationDate
conestat alfaRuconestSalix Pharmaceuticals Ltdacute angioedema attacks in patients with hereditary angioedema04/16/2014 PDUFA
ofatumumabArzerraGlaxoSmithKline PLCchronic lymphocytic leukemia04/19/2014 PDUFA
morphine + oxycodoneMoxduoQRX PHARMAmoderate to severe acute pain04/22/2014 AdComm
omeprazole + aspirinPA32540/PA8140 POZEN Inc.secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers04/25/2014 PDUFA
Undisclosed Éclat product Flamel Technologies SAundisclosed Éclat product04/28/2014 PDUFA
CangrelorThe Medicines Co.percutaneous coronary intervention or cardiac stent procedures or those that require bridging from oral antiplatelet therapy to surgery04/30/2014 PDUFA
morphine hydrochlorideMOXDUO QRX PHARMAmoderate to severe acute pain05/25/2014 PDUFA
testosteroneCompleoTRT Trimel Pharmaceuticals Corp.bioadhesive intranasal gel formulation of testosterone05/28/2014 PDUFA
ferric citrateZerenexKeryx Biopharmaceuticals Incelevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis06/07/2014 PDUFA
bupropion hydrochlorideContraveOrexigen Therapeutics Inc.weight loss and maintenance of weight loss06/10/2014 PDUFA
Lymphoseek Injection ?Navidea Biopharmaceuticals, Inc.sentinel lymph node detection in patients with head and neck cancer06/16/2014 PDUFA
Tedizolid phosphateTR-701Cubist Pharmaceuticals Incacute bacterial skin and skin structure infections06/20/2014 PDUFA
insulin human [rDNA origin] AFREZZA Inhalation PowderMannKind Corp.type I or type II diabetes07/15/2014 PDUFA
conestat alfaRuconest Salix Pharmaceuticals Ltdhereditary angioedema07/16/2014 PDUFA

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