Wednesday, July 15, 2009

Multaq Approval

The FDA approved MULTAQ (NDA#022425) on 7/1/09. The active ingredient is DRONEDARONE. The drug is manufactured by Sanofi Aventis US.

This is a heart drug that was rejected three years ago due to concerns about patient deaths.

This drug is going to be used to treat artrial fibrillation or atrial flutter. Multaq is an anti-arrhythmic 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.

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