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MULTAQ(R) (dronedarone) for Atrial Fibrillation or Atrial Flutter Now Available in the United States
Date:7/28/2009

BRIDGEWATER, N.J., July 28 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that MULTAQ((R)) (dronedarone) 400 mg Tablets is now available in pharmacies in the United States. MULTAQ is an anti-arrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted.

MULTAQ was recently approved by the U.S. Food and Drug Administration on July 1, 2009.

"MULTAQ may help patients with atrial fibrillation or atrial flutter stay out of the hospital, which is an important factor in treatment that is often not addressed," said Gerald V. Naccarelli, M.D., Chief, Division of Cardiology, Pennsylvania State University College of Medicine. "We welcome a new option that may help patients with Afib or Aflutter manage their disease."

In the landmark ATHENA trial, the efficacy and safety of MULTAQ was evaluated in patients with AF/AFL or a recent history of these conditions (71% of these patients had no heart failure, 29% had NYHA class I-III stable heart failure). This trial showed that MULTAQ 400 mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% (p<0.001) when compared to placebo, meeting the study's primary endpoint. This reduction was generally consistent across study subgroups based on baseline characteristics or medications. Patients taking MULT
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