Glenmark Pharmaceuticals said it has received a tentative nod from US Food and Drug Administration for generic version of Cardiac drug Multaq. Dronedarone Tablets available in the strength of 400 mg tablets which is equivalent of Sanifo-Aventis Multaq Tablet 400 mg.
The company cannot sell the product in the United States as it is involved in a patent litigation with Sanofi in the district court of Delaware. Sanofi and Sanofi-Aventis filed the suit against Glenmark and Actavis on 26th February, 2014 in US court seeking to prevent the duo from commercializing its Abbreviated New Drug Application product prior to the expiration of certain US patents.
The company's current portfolio consists of 104 products authorized for distribution in the US marketplace and 62 Abbreviated New Drug Applications pending approval with the USFDA.
Glenmark Pharmaceuticals
