Alembic Pharmaceuticals Receives USFDA Final Approval for Dapagliflozin Tablets

Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB. Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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, making it eligible for 180 days of shared generic drug exclusivity. The estimated market size of Dapagliflozin Tablets, 5 mg and 10 mg, is US$ 10,487 million for twelve months ending December 2025 according to IQVIA.