Zydus Lifesciences Wins FDA Approval for Diabetes Drug

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration for dapagliflozin tablets in 5 mg and 10 mg strengths.

The approved drug used in the reference is and the Farxiga tablets, which are also marketed in the same dosage. The approval is another milestone to Zydus since it is a boost in their presence within the competitive market in the U.S. in the field of generics.

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is recommended to be used along with diet and physical activity to assist in the glycemic control of patients with type 2 diabetes mellitus. The medication is crucial in the treatment of diabetes particularly to those patients who require improved blood sugar control as well as lifestyle interventions.

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The dapagliflozin tablets that have been approved will be manufactured in the formulation manufacturing plant of the group that is in SEZ, Ahmedabad. This plant is also sustaining the global supply chain that Zydus is developing, especially to controlled markets such as the United States.

Dapagliflozin is one of the key products of the market in the U.S in commercial terms. IQVIA MAT December 2025 data show that the tablets had an annual sales of USD 10,486.9 million in the United States. This illustrates the size of the potential of firms that are in this segment of therapy.

This approval has seen Zydus Lifesciences to have 430 FDA approvals. The company has submitted 505 ANDAs, since it started the filing process in FY 2003-04: it has a long-term orientation towards the development of a powerful and diversified portfolio of generics.