FDA Advisory Committee Meeting: Arymo™ Extended Release Briefing Document: August 4, 2016

On August 4, 2016, the Federal Food and Drug Administration (FDA) published this meeting briefing document on Arymo™ (morphine sulfate) extended release (ER) tablets. The joint Advisory Committee meeting provided a forum for the Committee members to discuss and provide guidance to the FDA on the approvability and abuse-deterrent labeling language for Arymo ER; and this resulting document provided the Committee members with data needed to assist in making these determinations and answering the questions posed by the FDA . . .