Pain Therapeutics confirms PDUFA date for Remoxy (oxycodone extended release).
Pain Therapeutics has announced that the FDA has determined that an Advisory Committee meeting for Remoxy, which had been tentatively scheduled for August 5, 2016, is unnecessary and will not be held. Remoxy was previously the subject of an Advisory Committee meeting in 2008. Pain Therapeutics also stated that the FDA advised them that the regulatory review of the Remoxy New Drug Application (NDA) remains active and on-going.
The Prescription Drug User Fee Act (PDUFA) date for the Remoxy NDA of September 25, 2016 is unchanged.
Comment: Remoxy is an abuse deterrent formulation of extended-release oxycodone (CII) capsules .
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.