Biocon Pharma, a subsidiary of Biocon, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Dapagliflozin Tablets, 5 mg and 10 mg.
The approved product is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control, and reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
This approval further strengthens Biocon’s expanding diabetes portfolio, which spans oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides, reinforcing the Company’s integrated approach to addressing the evolving needs of people living with diabetes globally.
Dapagliflozin Tablets will be manufactured at Biocon’s FDA-approved facilities, in compliance with global quality and regulatory standards.
