Zydus Lifesciences Ltd has received tentative approval from the US Food and Drug Administration for Dapagliflozin tablets in 5 mg and 10 mg strengths. The approval allows the company to market the product in the US once patent and exclusivity conditions are resolved.
Zydus Lifesciences announced that it has received tentative approval from the US Food and Drug Administration for its Dapagliflozin tablets, available in 5 mg and 10 mg dosages. The approval was granted under the Abbreviated New Drug Application pathway.
Dapagliflozin is a widely used oral anti-diabetic medication prescribed for the management of type 2 diabetes and certain cardiovascular and renal conditions. Tentative approval indicates that Zydus’ product meets the USFDA’s quality, safety, and efficacy requirements but cannot be marketed until existing regulatory exclusivities expire.
The development strengthens Zydus Lifesciences’ presence in the US generics market and enhances its diabetes-focused portfolio. It also reflects the company’s continued focus on complex and chronic therapy segments in regulated markets.
Key Regulatory Update
Tentative approval received for Dapagliflozin tablets in 5 mg and 10 mg strengths
Approval granted under the USFDA’s ANDA framework
Strategic Importance
Expands Zydus’ diabetes and chronic care product pipeline
Supports long-term growth prospects in the US generics market
Industry Context
Generic diabetes drugs remain a key focus area due to rising global prevalence
Regulatory approvals are critical milestones for market entry and revenue scalability
Sources : Company Regulatory Filing, USFDA Disclosure, Reuters