Alembic Pharmaceuticals Gets USFDA Nod For Generic Dapagliflozin Tablets

Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic version of dapagliflozin tablets used to control blood sugar levels in people with type-2 diabetes.

The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of dapagliflozin tablets of strengths 5 mg and 10 mg, Alembic Pharmaceuticals Ltd said in a regulatory filing.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca), it added.

Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. With this approval, Alembic is eligible for 180 days of shared generic drug marketing exclusivity, the company said.

Dapagliflozin tablet is indicated to reduce the risk of hospitalisation for heart failure in adults with type-2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.

It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus, the company said.