Home / Business and Economy / Zydus Lifesciences Secures FDA Tentative Approval for Diabetes Drug
Zydus Lifesciences Secures FDA Tentative Approval for Diabetes Drug
27 Nov
Summary
- Zydus Lifesciences received tentative US FDA approval for diabetes tablets.
- The approval is for empagliflozin and linagliptin combination strengths.
- The drug is an adjunct for type 2 diabetes treatment alongside diet and exercise.
Zydus Lifesciences announced it has received tentative approval from the United States Food and Drug Administration (FDA) for its empagliflozin and linagliptin tablets. These tablets, available in 10 mg/5 mg and 25 mg/5 mg strengths, are indicated as a supplementary treatment for adults with type 2 diabetes, to be used alongside diet and exercise when both active ingredients are deemed appropriate.
The combination of empagliflozin and linagliptin is a significant market with annual sales reaching $215.8 million in the United States for the period ending September 2025. This tentative approval positions Zydus to further expand its presence in the diabetes management sector, building on its existing portfolio of 428 approvals.
In parallel, Zydus Lifesciences recently announced robust financial performance. The company's consolidated net profit surged by 39% year-on-year to ₹1,259 crore. This growth was fueled by strong business momentum across various geographies and significant forex gains, alongside a 17% increase in revenue to ₹6,123 crore.
