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10th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today 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 U.S. LLC (Sanofi-Aventis). Dronedarone is indicated to reduce the risk of hospitalization for atrial 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.
Alembic has received year to date (YTD) 19 approvals (13 final approvals and 6 tentative approvals) and a cumulative total of 158 ANDA approvals (136 final approvals arid 22 tentative approvals) from USFDA.