Zydus Gets USFDA Nod for Diabetes Drug
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Zydus Lifesciences receives USFDA approval to market generic Empagliflozin and Linagliptin tablets for type 2 diabetes. Production in Ahmedabad.
New Delhi, Nov 27 (PTI) 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.
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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