Zydus Lifesciences has secured tentative approval from the United States Food and Drug Administration (USFDA) to market a generic version of Dapagliflozin tablets in the US, marking a significant regulatory milestone for the Ahmedabad-based pharmaceutical company.
The approval covers Dapagliflozin tablets in 5 mg and 10 mg strengths, an SGLT2 (sodium-glucose cotransporter-2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Zydus plans to manufacture the tablets at its formulation facility in the SEZ area of Ahmedabad, India. Industry data show that the Dapagliflozin segment has historically had strong demand in the US market, with annual sales estimated at over USD 10.4 billion, reflecting the commercial potential of the generic version.
Tentative approval from the USFDA allows Zydus to market the generic drug in the United States once all regulatory conditions are fulfilled, potentially enhancing its presence in one of the world’s largest markets for diabetes therapies.
