Alembic Pharmaceuticals Receives USFDA Final Approval for Dapagliflozin Tablets
Alembic Pharmaceuticals Limited announced today that it has secured final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, available in strengths of 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, manufactured by AstraZeneca AB. Dapagliflozin tablet, which is an SGLT2 inhibitor, is indicated for two uses. It is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple...