Alembic Pharma gets tentative nod from USFDA for diabetes management drug

The product is therapeutically equivalent to Synjardy tablets of Boehringer Ingelheim Pharmaceuticals, Inc

Drug firm Alembic Pharmaceuticals on Monday said it has received tentative approval from the US health regulator for Empagliflozin and Metformin Hydrochloride tablets, used for the management of type-2 diabetes.

The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Empagliflozin and Metformin Hydrochloride tablets in the strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg, Alembic Pharmaceuticals said in a regulatory filing.

The tentatively approved product is therapeutically equivalent to Synjardy tablets of Boehringer Ingelheim Pharmaceuticals, Inc.

Alembic Pharma said it is currently in litigation