Sanofi-Aventis (SNY) said that the US Food and Drug Administration has approved Multaq 400 mg Tablets. Multaq is an anti-arrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation, or AF, or atrial flutter, or AFL, with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.
The company specified that the FDA approval is based on five international, multi-center, randomized clinical trials involving nearly 6300 patients.
For comments and feedback: editorial@rttnews.com