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Pain Therapeutics Announces FDA Advisory Committee Meeting for REMOXY

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Additional Relevant Details Pain Therapeutics, Inc. announced today that an Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the REMOXY New Drug Application (NDA), tentatively scheduled for Friday, August 5, 2016. This is intended to be a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee."This could be a prime opportunity to showcase the abuse-deterrence and other properties of our lead drug candidate, REMOXY," said Remi Barbier, President & CEO of Pain Therapeutics. "We look forward to sharing our data with the FDA, Committee members and the general public."FDA also advised us that the Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA, September 25, 2016, is unchanged.
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Jul 01, 2016
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Related Keywords Advisory Committee, Remoxy