Biocon Pharma Gains U.S. FDA Approval for Dapagliflozin Tablets
Biocon Pharma Limited, a subsidiary of Biocon Limited, announced on April 8, 2026, that it has secured approval from the U.S. Food and Drug Administration (FDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg.The approved indication for the product is for the management of adults with type 2 diabetes mellitus. It is indicated to be used 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 also have either established cardiovascular disease or multiple cardiovascular risk factors.
This FDA approval marks a significant development for Biocon's expanding diabetes portfolio. The company's portfolio is noted to span oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides, reinforcing the company's comprehensive strategy to meet the global requirements for diabetes care.
Dapagliflozin Tablets will be manufactured at facilities belonging to Biocon that hold FDA approval, ensuring adherence to international quality and regulatory standards.
BIOCON Stock Price Movement
Shares of Biocon Limited on Tuesday slipped by 4.15% to settle at ₹340.05. The stock experienced substantial movement, recording a total traded volume of 15.93 million shares.Source:
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