The company received final approval from the USFDA for its New Drug Application (NDA) for ZITUVIMETTM (Sitagliptin and Metformin Hydrochloride) tablets, 50 mg/500 mg and 50 mg/1000 mg.
November 06, 2023, Ahmedabad, India
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIMETTM (Sitagliptin and Metformin hydrochloride) tablets, 50 mg/500 mg and 50 mg/1000 mg.
ZITUVIMETTM contains active ingredients sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The approval of ZITUVIMETTM is based on research, development, regulatory, and manufacturing work performed by Zydus teams. ZITUVIMETTM has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards. ZITUVIMETTM is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products.
“The ZITUVIMETTM approval further builds on our previous approval of ZITUVIOTM (Sitagliptin) and offers an increased accessibility and affordability to healthcare systems with regard to prescription drugs for type II diabetes. 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,” said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited.
According to IQVIA™ (MAT Aug-2023), U.S. market for DPP-IV inhibitors and their combinations is US$ 10 bn.