Celgene Corporation 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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