Zydus Lifesciences Receives US Health Regulator's Nod To Market A Generic Diabetes Drug

Zydus Lifesciences Receives US Health Regulator's Nod To Market A Generic Diabetes Drug

Zydus Lifesciences received approval from the US health regulator to market a generic diabetes drug.The tablets in combination are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Linagliptin is appropriate. The product will be produced at the group's formulation manufacturing facility.

PTIUpdated: Friday, November 28, 2025, 09:30 AM IST
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New Delhi: Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market a generic diabetes drug.The company has received tentative approval from the US Food and Drug Administration (USFDA) for Empagliflozin and Linagliptin tablets, a statement said.

The tablets in a combination are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Linagliptin is appropriate.The product will be produced at the group's formulation manufacturing facility at SEZ, Ahmedabad, the drug maker said.As per the IQVIA MAT September-2025 data, Empagliflozin and Linagliptin tablets had annual sales of USD 215.8 million in the US. 

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