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Opioid Dispute Resolution Denied By US FDA In Part Because Of Dueling Requests

 
• By Michael Cipriano

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.

After receiving a complete response letter (CRL) for its immediate-release (IR) formulation of oxycodone hydrochloride, Pharmaceutical Manufacturing Research Services, Inc. (PMRS) requested a hearing on the US FDA's decision, arguing that the agency should not grant abuse-deterrent claims based on pre-marketing data while simultaneously seeking abuse-deterrent labeling for its own product, the agency say.

But FDA denied the company's request for such a hearing, leaving the sponsor a clear message: You can't have it both ways.

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