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Dronedarone advisory committee review

Executive Summary

FDA's Cardiovascular and Renal Drugs Advisory Committee is meeting March 18 to discuss Sanofi-Aventis' NDA for Multaq (dronedarone) 400 mg oral tablets, proposed for patients with a history of, or current, atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalization or death. The NDA is based on the recently published ATHENA study (1"The Pink Sheet" DAILY, Aug. 11, 2008)

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