Biocon Pharma Receives U.S. FDA Approval for Dapagliflozin Tablets

Biocon Pharma Limited, a subsidiary of Biocon Limited, has 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 strengthens Biocon’s expanding diabetes portfolio, which includes oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides. The Dapagliflozin Tablets will be manufactured at Biocon’s FDA-approved facilities, in compliance with global quality and regulatory standards.