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February 28, 2014
08:03 EDTSNY, ACTActavis confirms generic Multaq patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's (SNY) Multaq, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent AF. Sanofi and Sanofi-Aventis U.S. filed suit against Actavis on February 26 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until Jan. 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
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