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Alembic gets US FDA approval for 1st generic of Lilly's diabetes drug Jardiance

Alembic Pharmaceuticals Ltd. secured tentative approval from the U.S. Food and Drug Administration to market a generic version of diabetes drug Jardiance that is co-marketed by Eli Lilly and Co. and Boehringer Ingelheim GmbH.

Gujarat, India-based Alembic's drug is the first generic of Jardiance to gain approval in the U.S.

Jardiance, or empagliflozin, was first approved by the FDA in 2014 to control blood sugar in patients with type 2 diabetes. The U.S. regulator expanded the indication in 2016 to lower the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease.