Zydus Lifesciences announced that it has received a final approval from the United States Food and Drug Administration (USFDA) for its new drug application (NDA) to market Zituvimet XR(sitagliptin and metformin hydrochloride) tablets.
With this, Zydus has all three NDAs of sitagliptin (base) and combination franchise approved through the 505(b)(2) route. Notably, all the three NDAs achieved first-cycle approval (FCA), it added
Zituvimet XR tablets (sitagliptin and metformin hydrochloride) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The drug will be manufactured at the groups formulation manufacturing facility in Ahmedabad SEZ - II, India.
According to IQVIA MAT May 2024, U.S. market for DPP-IV inhibitors and its combinations is $9.5 billion.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
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The pharma major reported consolidated net profit of Rs 1,182.3 crore in Q4 FY24 steeply higher than Rs 296.6 crore recorded in Q4 FY23. Revenue from operations jumped 10.44% to Rs 5,533.8 crore during the quarter as compared with Rs 5,010.6 crore posted in corresponding quarter last year.
Shares of Zydus Lifesciences declined 2.33% to currently trade at Rs 1,157.70 on the BSE.
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