Glenmark Pharmaceuticals said that it has got the US health regulator’s tentative approval for generic version of Sanofi-Aventis’ cardiac drug Multaq.
Glenmark said in a BSE filing that it “has been granted tentative approval by the US Food & Drug Administration (USFDA) for its Dronedarone Tablets, 400 mg, the generic version of Multaq Tablet, 400 mg of Sanofi-Aventis US LLC.”
The company, however cannot sell the product in the US as it is involved in a patent litigation with Sanofi in the district court of Delaware.
