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Multaq Panel Resolves Mortality Concerns, Looks At Restricted Claims

Executive Summary

With two sets of conflicting data in front of them, the Cardiovascular and Renal Drugs Advisory Committee's first task for its review of Sanofi-Aventis' Multaq was to determine if the results were compatible. In the end, swayed by the positive findings in a narrower population, the committee supported a limited approval for dronedarone

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Sanofi Halts Multaq Trial Early Due To Cardiac Events

Sanofi is facing another safety issue with its antiarrhythmic drug Multaq (dronedarone) with the termination of a Phase IIIb clinical trial in patients with permanent atrial fibrillation due to an increase in cardiovascular events.

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