Abuse-Deterrent Opioids: FDA Regulatory Options Aired At Meeting

Brand industry favors two- to three-year period for withdrawal or reformulation of products without abuse-deterrent features, while generic industry calls for expedited review pathway. Purdue and Zogenix agree to waive three-year market exclusivity for their respective hydrocodone products.

FDA is considering when it should deny approval or withdraw approval of opioids that lack abuse-deterrent features and sought input on the issue during a two-day public meeting.

The Oct. 30-31 meeting on the development and regulation of abuse-deterrent opioid medications focused on manufacturing and regulatory challenges and...

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