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Re: None

Wednesday, 10/31/2018 11:48:55 PM

Wednesday, October 31, 2018 11:48:55 PM

Post# of 1319
Trevena’s New Drug Application (NDA) submission for oliceridine was accepted for review by the FDA on January 2, 2018 with a Prescription Drug User Fee Act (PDUFA) target date for completion of review by the FDA of November 2, 2018. The FDA is not bound by the Advisory Committee's recommendations but takes its advice into consideration when making its decision.

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