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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Drug Rejection Hearings Are Having A Moment At US FDA
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.
PMRS Continues Campaign Against Other Abuse Deterrent Opioid Products
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.
Opioid Dispute Resolution Denied By US FDA In Part Because Of Dueling Requests
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.