Prasugrel Receives Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The NDA for prasugrel, a treatment for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI), has received priority review status from the FDA. Prasugrel, submitted by Daiichi Sankyo Co. and  Eli Lilly, is likely to receive notice of action within six months of its Dec. 26, 2007 submission date. “We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with...

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