Celgene Corporation Announces Pomalidomide Will be Reviewed at FDA Advisory Committee
Published: Sep 19, 2012
SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will hold a review of the Company’s new drug application (NDA) for pomalidomide at its meeting on November 8, 2012. The Company is seeking approval to market pomalidomide in combination with dexamethasone as a potential treatment for patients with relapsed and refractory multiple myeloma that has progressed following at least two prior therapies. The agency has set a Prescription Drug User Fee Act (PDUFA) date of Feb. 10, 2013 for completion of the review.