Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, 5 mg and 10 mg.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca.

Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of hospitalisation for heart failure in adults with type-II 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 glycaemic control in adults with type-II diabetes mellitus.

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

Dapagliflozin tablets, 5 mg and 10 mg, have an estimated market size of USD 10,487 million for the 12 months ending December 2025, according to IQVIA.

Alembic has a cumulative total of 235 ANDA approvals from USFDA, including 217 final approvals and 18 tentative approvals.