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Sanofi-Aventis Gets Priority Review For Second-Generation Atrial Fib Drug

This article was originally published in The Pink Sheet Daily

Executive Summary

Approval could come in early 2009 for Cordarone successor Multaq.

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Dronedarone advisory committee review

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)

Dronedarone advisory committee review

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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