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The anti-arrhythmic dronedarone has been approved by the FDA for maintenance of normal sinus rhythm in patients with a history of atrial fibrillation or atrial flutter.

Dronedarone Approved

Dronedarone Approved

The anti-arrhythmic dronedarone has been approved by the FDA for maintenance of normal sinus rhythm in patients with a history of atrial fibrillation or atrial flutter. It is indicated for patients who have returned to sinus rhythm or who will be undergoing cardioversion. Dronedarone, which is closely related to amiodarone, was approved after a large trial showed that the drug reduced cardiovascular hospitalization or death from any cause by 24% when compared to placebo. This is the second time that the FDA has considered dronedarone. The drug was rejected in 2006 because of safety concerns in patients with heart failure, and the new approval carries a box warning cautioning against use in patients with severe heart failure. As opposed to amiodarone, dronedarone does not have an iodine moiety and also is less lipophilic, potentially resulting in less thyroid and neurologic toxicity. Dronedarone will be marketed by Sanofi-Aventis as Multaq®.