Celgene Says No ODAC Meeting November 8, PDUFA Date Remains Feb 10 2013 for Pamalidomide
Celgene Corporation (NASDAQ: CELG) today announced it was notified by the U.S. Food and Drug Administration (FDA) that there will not be an Oncologic Drugs Advisory Committee (“ODAC”) meeting scheduled for November 8, 2012. The agency has informed the Company the review of its new drug application (“NDA”) for pomalidomide is continuing with the previously announced Prescription Drug User Fee Act (PDUFA) action date remaining Feb. 10, 2013. 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.
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