Zydus Lifesciences on Monday, November 6, said it has received the final approval from the United States Food and Drug Administration (USFDA) for Zituvimet to treat adult patients with type 2 diabetes mellitus.
Zituvimettm tablets in the strength of 50 mg/500 mg and 50 mg/1000 mg comprise active ingredients sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, Zydus Lifesciences said in a stock exchange filing. The new drug is used to improve glycemic control in adults with type 2 diabetes mellitus.
The pharma company said Zituvimet has undergone quality testing for Nitrosamines and potential genotoxic impurities as per the present USFDA standards. The new product is also compliant with present USFDA standards of Nitrosamines in Sitagliptin containing products.
According to IQVIA data, the US market for DPP-IV inhibitors and their combinations is $10 billion at the 12 months ended August 2023.
"The Zituvimet approval further builds on our previous approval of Zituvimet (Sitagliptin) and offers an increased accessibility and affordability to healthcare systems with regard to prescription drugs for type II diabetes,” Sharvil Patel, the managing director of Zydus Lifesciences, said.
The Ahmedabad-based pharma major manufactures and markets a broad range of active pharmaceutical ingredients (API) and formulations. The Zydus group has research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim.
In September, Zydus Lifesciences received an establishment inspection report (EIR) from the USFDA for its facility at Pharmez in Ahmedabad with zero observations.
Shares of Zydus Lifesciences were trading 0.3% higher at ₹586.35 apiece on BSE at 9:34am.
(Edited by : Shloka Badkar)
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