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Not Your Typical Response: Oxycodone Sponsor Seeks FDA Hearing On Complete Response Letter

 
• By Brenda Sandburg

Data on abuse deterrence for Pharmaceutical Manufacturing Research Services' oxycodone immediate-release product are insufficient, FDA tells company.

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Pharmaceutical Manufacturing Research Services Inc. has requested an opportunity for a hearing with the US FDA after the agency sent a complete response letter detailing deficiencies with its new drug application for an immediate-release oxycodone product.

The agency announced its proposal to refuse to approve the NDA and the company's request for a hearing in a Federal Register

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