FDA Calendar

Advisory Committee and PDUFA Date Activity

Generic Name Trade NameOriginatorIndicationDate
Suvorexant tabletsMerck & Co Inc.insomnia05/22/2013 AdComm
CHEMOSAT with melphalan hydrochlorideDelcath Hepatic CHEMOSATDelcath Systems Inc.metastatic melanoma in liver06/15/2013 PDUFA
Sugammadex sodium injectionBRIDIONMerck & Co Inc.routine reversal of moderate and deep neuromuscular blockade07/18/2013 AdComm
Tivozanib TIVOPATHAVEO Pharmaceuticals, Inc.advanced renal cell carcinoma07/28/2013 PDUFA

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