FDA Approves Multaq(R) For Patients With Atrial Fibrillation Or Atrial Flutter

Sanofiaventis (EURONEXT SAN and NYSE SNY) announced that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq(R) is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.

Multaq(R) is an antiarrhythmic 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, who are in sinus rhythm or who will be cardioverted. Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular ejection fraction [LVEF]

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This entry was posted on Viernes, Julio 3rd, 2009 at 19:40 and is filed under pharma industry. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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