Alembic Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic version of dapagliflozin tablets, used in the treatment of type-2 diabetes.

The approval covers the company’s abbreviated new drug application (ANDA) for 5 mg and 10 mg strengths of the drug.

The generic formulation is therapeutically equivalent to the reference listed drug Farxiga Tablets, developed by AstraZeneca AB.

This approval strengthens Alembic Pharma’s presence in the US generics market and expands its portfolio in the anti-diabetic segment.