Abuse-Deterrent Opioids: FDA Regulatory Options Aired At Meeting
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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.
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