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Actavis plc confirms generic multaq patent challenge


Friday, 28 Feb 2014 08:00am EST 

Actavis plc:Confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Dronedarone Hydrochloride Tablets 400 mg.Says its ANDA product is a generic version of Sanofi's Multaq, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF. 

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