ZITUVIOTM from Zydus has been given USFDA approval for the treatment of type 2 diabetes mellitus in adults

23 Oct 2023 , 10:39 AM

The U.S. Food and Drug Administration (FDA) has given the green light to Zydus Lifesciences Limited’s (also known as ‘Zydus’) New Drug Application (NDA) for ZITUVIOTM (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.

Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is the main ingredient in ZITUVIOTM. It is recommended as an addition to diet and exercise to enhance glycemic control in persons with type 2 diabetes mellitus.

The research, development, regulatory, and manufacturing efforts done by Zydus teams established the basis for ZITUVIOTM’s approval. According to current USFDA guidelines, ZITUVIOTM has undertaken quality testing for nitrosamines and potentially genotoxic contaminants. ZITUVIOTM complies with the most recent USFDA regulations on Nitrosamines in products containing sitagliptin.

According to Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, ‘The ZITUVIOTM approval builds on Zydus’ long-term commitment to offer healthcare professionals a new, reasonably priced treatment option in connection with diabetes management.’

‘We are grateful to have Zydus gain such a significant approval. We take pride in developing creative methods to add value to the healthcare systems by giving our patients access to affordable medications thanks to our sector-leading skills. Future breakthrough medicines that support our mission of enabling patients to lead healthier and more fulfilling lives are something we look forward to bringing to market, said Dr. Punit Patel, CEO of Zydus Pharmaceuticals, Americas.

The U.S. market for DPP-IV inhibitors and their combinations is estimated to be at US$ 10 billion by IQVIATM.

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