Alembic Pharmaceuticals Ltd announced that it had got approval from the US Food and Drug Administration (FDA) to market Dronedarone tablets, which decrease the risk of hospitalisation for atrial fibrillation. The company has also got approval from the FDA for its Abbreviated New Drug Application (ANDA) for its medication in the strength of 400 mg, the drugmaker said in a statement.

The tentatively approved ANDA is like the Sanofi-Aventis’ Reference Listed Drug (RLD) product Multaq Tablets. Dronedarone can reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.