Biocon Pharma Secures USFDA Nod for Dapagliflozin Tablets

Biocon Pharma Ltd, a division of Biocon Ltd, received USFDA approval for its generic dapagliflozin tablets. These tablets aid in managing blood sugar levels in adults with type 2 diabetes. This approval enhances Biocon's diabetes portfolio, which includes various treatment forms for diabetes management.

Biocon Ltd announced on Wednesday that Biocon Pharma Ltd, its subsidiary, has obtained approval from the U.S. Food and Drug Administration (USFDA) for their genetic version of dapagliflozin tablets. These tablets are intended to help reduce blood sugar levels in adults with type 2 diabetes mellitus.

The USFDA approval covers dapagliflozin tablets in strengths of 5 mg and 10 mg. According to Biocon, these tablets are designed to aid adults with type 2 diabetes in improving glycemic control when combined with diet and exercise. Additionally, they help reduce the risk of hospitalization due to heart failure in patients with type 2 diabetes and cardiovascular risks.

As part of Biocon's regulatory filing, the company highlighted that this development underscores its expanding diabetes treatment portfolio. It includes oral solid dosage forms, biosimilar insulin, and complex GLP-1 peptides. Biocon's FDA-approved facilities will manufacture the dapagliflozin tablets, ensuring compliance with global quality and regulatory standards.