Biocon Limited has informed the Exchange regarding 'Company Statement'.
BIOCON · price
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Biocon Pharma Limited, a subsidiary of Biocon Limited, has received approval from the U.S. Food and Drug Administration (FDA) for Dapagliflozin Tablets in 5 mg and 10 mg dosages. The drug is indicated for treating adults with type 2 diabetes as an adjunct to diet and exercise, improving glycemic control and reducing heart failure hospitalization risks in patients with cardiovascular disease or multiple risk factors. The product will be manufactured at Biocon's FDA-approved facilities. This approval expands Biocon's diabetes portfolio which includes oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides.
Positive for shareholders as FDA approval opens access to the large U.S. diabetes market, strengthening Biocon's global diabetes franchise and potential revenue streams from hard currency markets.