The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD) Multaq Tablets of Sanofi-Aventis U.S. LLC.

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.

The tablets 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.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

On a consolidated basis, the drug maker's net profit dropped 49.22% to Rs 169.29 crore on 11.31% decline in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.