Biocon Pharma Limited, a subsidiary of Biocon Limited, has announced the receipt of approval from the U.S. Food and Drug Administration (FDA) for its Dapagliflozin Tablets, available in 5 mg and 10 mg dosages. This product is designed for the treatment of adults with type 2 diabetes mellitus, serving as an adjunct to diet and exercise to enhance glycemic control. Additionally, it aims to reduce the risk of hospitalisation due to heart failure in adults with type 2 diabetes mellitus who have either established cardiovascular disease or multiple cardiovascular risk factors.
The approval of Dapagliflozin Tablets marks a significant addition to Biocon’s expanding diabetes portfolio, which includes oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides. This development underscores Biocon’s commitment to providing an integrated approach to addressing the evolving needs of individuals living with diabetes on a global scale.
The manufacturing of Dapagliflozin Tablets will take place at Biocon’s FDA-approved facilities, ensuring compliance with global quality and regulatory standards.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).