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Does Purdue’s Reformulated OxyContin ER Really Deter Abuse? US FDA Panel To Decide

Executive Summary

Five years after an advisory committee meeting was cancelled, panel will consider whether required postmarketing studies show Purdue’s reformulated opioid ‘meaningfully’ reduces abuse and overdose.

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‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA

Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.

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