Zydus Lifesciences announced that the U.S. Food and Drug Administration (USFDA) approved its New Drug Application (NDA) for ZITUVIO (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.
The drug is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The approval of ZITUVIO is based on research, development, regulatory and manufacturing work performed by Zydus teams. ZITUVIO has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards. ZITUVIO is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products.
According to IQVIA (MAT Aug-2023), U.S. market for DPP-IV inhibitors and its combinations is $10 billion.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company had reported 109.7% surge in net profit to Rs 1,086.9 crore in Q1 FY24 as compared with Rs 518.3 crore posted in Q1 FY23. Revenue from operations jumped 29.6% to Rs 5,139.6 crore during the quarter as compared with Rs 3,964.4 crore recorded in same quarter last year.
The stock declined 1.82% to settle at Rs 578.55 on 20 October 2023.