Alembic Pharmaceuticals receives USFDA tentative approval for Dronedarone Tablets

14 Jan 2022 , 01:35 AM

Alembic Pharmaceuticals announced that it has received tentative approval from the US Food Drug Administration USFDA 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 product RLD Multaq Tablets 400 mg of Sanofi-Aventis US 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