New Delhi, April 8 Biocon Ltd announced on Wednesday that its subsidiary, Biocon Pharma Ltd, has received approval from the US health regulator for its genetically engineered version of dapagliflozin tablets, indicated for reducing blood sugar levels in adults with type 2 diabetes mellitus.
The approval from the US Food and Drug Administration (USFDA) is for dapagliflozin tablets in strengths of 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 to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus who have either established cardiovascular disease or multiple cardiovascular risk factors, it added.
This approval further strengthens Biocon's growing diabetes portfolio, which includes 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.