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U.S.FDA extends PDUFA date for Megace

Published in AIDS Weekly, May 16th, 2005

Par Pharmaceutical Companies, Inc recently announced that it was notified by the U.S. Food and Drug Administration (FDA) that it has extended the original 10-month Prescription Drug User Fee Act (PDUFA) goal date for the completion of its review of Par's New Drug Application (NDA) for Megace ES (megestrol acetate) oral suspension.

The extension results from Par's recent submission, at the FDA's request, of existing supplemental data on Megace ES. In accordance with FDA regulations, the new PDUFA goal date has been extended three months to July 29, 2005. Following discussions with the FDA, Par believes that the agency may complete its review of Megace ES prior to the new...

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Source: AIDS Weekly (2005-05-16)

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