Exelixis Says FDA Says NDA Has Been Removed from November Agenda
Exelixis (NASDAQ: EXEL) today was notified by the Food and Drug Administration (the “FDA”) that the Company's new drug application (“NDA”) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer has been removed from the agenda for the November 8 and November 9, 2012 meeting of the FDA's Oncologic Drugs Advisory Committee (“ODAC”). As a result, the Company does not anticipate a discussion of the NDA by ODAC. The previously announced Prescription Drug User Fee Act (PDUFA) action date remains November 29, 2012.
© 2015 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.