Trials & Filings

Pfizer Continues Remoxy E-R Development

Achieves technical milestones related to manufacturing

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer, having achieved technical milestones related to manufacturing, will continue the development program for Remoxy (oxycodone) Extended-Release Capsules CII. Following guidance received from the FDA earlier this year, Pfizer will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011.    These new clinical studies will include a pivotal bioequivalence study with the modified Remoxy formulation and an abuse-potent...

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