The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Multaq Tablets, 400 mg, of Sanofi-Aventis U.S. LLC (SanofiAventis). Dronedarone is indicated to reduce, the risk of hospitalization for atria) fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.

Dronedarone Tablets USP, 400 mg have an estimated market size of US$ 500 million for twelve months ending September 2021 according to IQVIA. Alembic has settled the case with Sanofi-Aventis and will launch its generic as per the terms of settlement.