Zydus Lifesciences Receives USFDA Approval for Dapagliflozin Tablets

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for Dapagliflozin Tablets in the strengths of 5 mg and 10 mg. The drug is the generic version of Farxiga tablets and is used to improve glycaemic control in adults with type 2 diabetes mellitus.

Dapagliflozin belongs to a class of medicines known as sodium-glucose cotransporter 2 inhibitors. These drugs help manage blood sugar levels by helping the body remove excess glucose through urine. The medication is prescribed along with diet and exercise to support better diabetes management.

Manufacturing and Market Opportunity

Zydus stated that the approved tablets will be manufactured at its formulation manufacturing facility located in the Special Economic Zone in Ahmedabad. The approval strengthens the company’s presence in the US generics market.

According to industry data, Dapagliflozin tablets recorded annual sales of approximately USD 10.2 billion in the United States for the 12 months ending February 2026, highlighting the strong market potential for the product.

Growing Generics Portfolio

With this approval, Zydus is also eligible for 180 days of shared generic drug exclusivity for the product. This allows the company and select generic manufacturers to market the drug before broader competition enters the market.

The company now has a total of 436 approvals from the USFDA and has filed 505 Abbreviated New Drug Applications since it began the filing process in the financial year 2003-04.

Conclusion

The latest approval further strengthens Zydus Lifesciences’ generics portfolio in the United States. By expanding its product pipeline and leveraging its manufacturing capabilities, the company continues to enhance its presence in one of the world’s largest pharmaceutical markets.

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