NEW DELHI: Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market generic Dronedarone tablets, which is used to reduce risk of hospitalisation for atrial fibrillation, in the American market.
The company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its medication in strength of 400 mg, the drug maker said in a statement.
The tentatively approved ANDA is therapeutically equivalent to Sanofi-Aventis’ Reference Listed Drug (RLD) product Multaq Tablets, 400 mg.
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.
Cumulatively, the company has so far received 158 ANDA approvals from USFDA.
Source: Press Trust of India