Zydus Lifesciences has secured tentative approval from the USFDA for its generic version of Empagliflozin and Linagliptin tablets. This approval opens the door for another treatment option in the fast-growing type 2 diabetes market.
The combination tablets are used as an adjunct to diet and exercise. They help improve glycaemic control in adults with type 2 diabetes who need treatment with both agents.
This approval adds another product to Zydus’ expanding diabetes portfolio.
The company continues to build its pipeline with a mix of cardio-metabolic therapies and complex generics.
The approved product will be manufactured at Zydus’ formulation facility in SEZ, Ahmedabad, a site known for supplying several high-volume regulated-market products.
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