Biocon Pharma Secures USFDA Approval for Dapagliflozin Tablets to Aid Diabetes Treatment
Biocon Pharma receives USFDA approval for Dapagliflozin Tablets, 5 mg and 10 mg
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Biocon Pharma, a subsidiary of Biocon, has received approval from the U.S. Food and Drug Administration (FDA) for Dapagliflozin Tablets in 5 mg and 10 mg dosages. This medication is designed to improve glycemic control and reduce heart failure hospitalization risks in adults with type 2 diabetes mellitus.
- 01Biocon Pharma has received FDA approval for Dapagliflozin Tablets.
- 02The tablets are available in 5 mg and 10 mg dosages.
- 03Dapagliflozin is used for adults with type 2 diabetes mellitus.
- 04The approval enhances Biocon's diabetes treatment portfolio.
- 05The tablets will be manufactured in FDA-approved facilities.
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Biocon Pharma, a subsidiary of Biocon, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Dapagliflozin Tablets in 5 mg and 10 mg dosages. This medication is indicated for adults with type 2 diabetes mellitus, serving as an adjunct to diet and exercise to improve glycemic control and reduce the risk of hospitalization for heart failure in patients with established cardiovascular disease or multiple cardiovascular risk factors. This FDA approval strengthens Biocon's diabetes portfolio, which includes oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides, demonstrating the company's commitment to meeting the evolving needs of individuals living with diabetes worldwide. The Dapagliflozin Tablets will be produced at Biocon's FDA-approved manufacturing facilities, ensuring compliance with global quality and regulatory standards.
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The approval of Dapagliflozin Tablets means more treatment options for adults with type 2 diabetes, potentially improving health outcomes and reducing hospital visits due to heart failure.
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