Alembic Pharmaceuticals receives US FDA tentative approval for Dronedarone tablets

Alembic Pharmaceuticals today received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dronedarone tablets USP, 400 mg. The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Multaq tablets, 400 mg, of Sanofi-Aventis US LLC (Sanofi-Aventis), the company said in a statement.

Dronedarone is indicated to reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation, it added.

Dronedarone tablets USP, 400 mg have an estimated market size of $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, concluded the statement.