Sanofi-Aventis’ Multaq Approved by FDA

The FDA has approved Sanofi-Aventis's Multaq (dronedarone) 400 mg tablets for patients with atrial fibrillation (AF) or atrial flutter (AFL).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has approved Sanofi-Aventis‘s Multaq (dronedarone) 400 mg tablets. Multaq, an anti-arrhythmic, is the first drug approved in the U.S. to show a clinical benefit to reduce cardiovascular hospitalization in patients with atrial fibrillation (AF) or atrial flutter (AFL), according to SA. The FDA’s approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients. “The FDA approval of Multaq is an important milestone in the manag...

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