Pfizer Gets CRL for Remoxy

Second complete response letter for ER oxycodone

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer and development partner Pain Therapeutics, Inc. (PTI) received a Complete Response Letter from the FDA on the resubmission of the NDA for Remoxy (oxycodone) Extended-Release Capsules CII. Pfizer is working to evaluate the issues described in the CRL and plans to have further discussions with FDA around them. The companies did not give any indication that the CRL would require further trials. Remoxy is an investigational extended-release oral formulation of oxycodone for the relief of mod...

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