Eisai Inc. Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010.

MORE ON THIS TOPIC