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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With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.
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.