FDA Grants Plavix Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Sanofi-Aventis and Bristol-Myers Squibb’s sNDA for Plavix for treatment of patients with acute ST-segment elevation myocardial infarction (STEMI) has been accepted for review by the FDA. STEMI is a heart attack in which an artery is generally blocked completely for sufficient time to cause heart muscle damage. This blockage is caused by clot formation in the arteries, which is also known as atherothrombosis. The FDA has designated the filing for priority review, which is granted to a...

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