The US Food and Drug Administration (FDA) has granted approval for Zydus Lifesciences’ new drug application for Zituvimet tablets (sitagliptin and metformin hydrochloride) 50mg/500mg and 50mg/1,000mg for type 2 diabetes mellitus in adults.
Zituvimet is intended for use as an adjunct to diet and exercise.
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By GlobalDataThe treatment could enhance glycaemic control in type 2 diabetes mellitus patients.
Zituvimet is a fixed-dose mixture of two active ingredients, sitagliptin and metformin hydrochloride (HCl).
Sitagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) and metformin hydrochloride is a biguanide.
Two dosages, sitagliptin 50mg and metformin HCl 500mg tablets; and sitagliptin 50mg and metformin HCl 1,000mg tablets, were approved by the regulator.
Zituvimet was also tested for genotoxic impurities and nitrosamines and was found to be compliant with the latest US FDA standards.
Zydus Lifesciences managing director Dr Sharvil Patel stated: “The Zituvimet approval further builds on our previous approval of Zituvio (sitagliptin) and offers increased accessibility and affordability to healthcare systems with regard to prescription drugs for type 2 diabetes.
“The Zituvimet approval provides an affordable treatment option for healthcare systems to reduce the rate of growth in drug spending, and improves the financial sustainability of the healthcare programmes.”
Zituvimet is not intended for treating type 1 diabetes mellitus patients and those with a history of pancreatitis.
