March 1, 2018 / 1:21 PM / 3 months ago

BRIEF-FDA Accepts Remoxy NDA For Review, Sets PDUFA Date Of Aug 7, 2018

March 1 (Reuters) - Pain Therapeutics Inc:

* FDA ACCEPTS REMOXY® NDA FOR REVIEW, SETS PDUFA DATE OF AUGUST 7, 2018

* U.S. FDA DETERMINED THAT A NDA FOR REMOXY ER IS SUFFICIENTLY COMPLETE TO PERMIT A SUBSTANTIVE REVIEW

* FDA HAS SET AN ACTION DATE OF AUGUST 7, 2018 UNDER PRESCRIPTION DRUG USER FEE ACT (PDUFA)

* PAIN THERAPEUTICS -BELIEVES FDA WILL HOLD AN OPEN ADVISORY COMMITTEE MEETING TO DISCUSS REMOXY ER, ALTHOUGH A DATE HAS NOT YET BEEN DETERMINED. Source text for Eikon: Further company coverage:

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