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Plavix sNDA priority review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb/Sanofi-Aventis' Plavix (clopidogrel) sNDA seeking a claim for treatment of acute ST-segment elevation myocardial infarction (STEMI) has a May 17 PDUFA goal date after being granted priority review status. The sponsors say data from ongoing clinical trials of Plavix in the STEMI setting will be presented at the American College of Cardiology annual meeting in March. The priority designation comes as BMS and Sanofi face patent challenges for the antithrombotic from generic firm Apotex. While BMS believes Plavix' patent expires in 2011, FDA granted final approval to Apotex' generic clopidogrel Jan. 20. "We are vigorously pursuing the pending patent litigation," Bristol CEO Peter Dolan said Jan. 25 during the firm's year-end earnings presentation...

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