Biocon Gets USFDA Nod for Dapagliflozin Tablets

New Delhi, Apr 8 (PTI) Biocon Ltd on Wednesday said its arm Biocon Pharma Ltd, has received approval from the US health regulator for its genetic version of dapagliflozin tablets indicated for reducing blood sugar in adults with type 2 diabetes mellitus.

The approval by the US Food and Drug Administration (USFDA) is for dapagliflozin tablets of strengths 5 mg and 10 mg, Biocon said in a regulatory filing.

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 hospitalisation for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, it added.


This approval further strengthens Biocon's expanding diabetes portfolio, which spans oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides, the company said.

It reinforces the company's integrated approach to addressing the evolving needs of people living with diabetes globally.

The dapagliflozin tablets will be manufactured at Biocon's FDA-approved facilities, in compliance with global quality and regulatory standards, it said.