Alembic Pharmaceuticals gets tentative nod from USFDA for diabetes management drug

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.

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