Not Your Typical Response: Oxycodone Sponsor Seeks FDA Hearing On Complete Response Letter
Data on abuse deterrence for Pharmaceutical Manufacturing Research Services' oxycodone immediate-release product are insufficient, FDA tells company.
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Latest citizen petition seeks to halt US FDA approval of Mallinckrodt's immediate release oxycodone abuse deterrent formulation; user fee action date is Nov. 16.
Pharmaceutical Manufacturing Research Services argued that its immediate-release oxycodone should be approved with abuse-deterrent labeling while simultaneously asserting that abuse-deterrent labeling should only be permitted based on postmarketing studies, FDA notes.
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