Zydus Lifesciences Limited received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application for Zituvimettm, a medication to treat adult patients with type 2 diabetes mellitus. The tablets contain active ingredients sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide.
This combination is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also compliant with the current USFDA standards for Nitrosamines in Sitagliptin-containing products.
“The Zituvimettm approval further builds on our previous approval of Sitagliptin and offers an increased accessibility and affordability to healthcare systems with regard to prescription drugs for type II diabetes,” said Dr Sharvil Patel, Managing Director of Zydus Lifesciences Limited. “The Zituvimettm 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 programs.”
However, the shares were down by 0.11 per cent to ₹583.95 per cent at 10.33 am on the BSE.