Dronedarone

FDA Drug Profile — Multaq

Drug Details

Generic Name
Dronedarone
Brand Names
Multaq
Application Number
NDA022425
Sponsor
Sanofi Winthrop Industrie
NDC Codes
4
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
DRONEDARONE

Indications and Usage

1 INDICATIONS AND USAGE MULTAQ ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) ] . MULTAQ 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 ( 1 , 14 ).