FDA approves Zydus Lifesciences’ ZITUVIO tablets for Type 2 diabetes

Zydus Lifesciences Limited announced today that the U.S. Food and Drug Administration (FDA) has granted approval for its New Drug Application (NDA) for ZITUVIO (Sitagliptin) tablets in three dosages: 25 mg, 50 mg, and 100 mg.

What is ZITUVIO?

Containing the active ingredient Sitagliptin, ZITUVIO functions as a dipeptidyl peptidase-4 (DPP-4) inhibitor. It’s specifically designed to be used alongside a balanced diet and regular exercise regimen to enhance glycemic control in adults diagnosed with type 2 diabetes mellitus.

ZITUVIO’s Development and Compliance

The green light for ZITUVIO has its foundations in the meticulous research, development, regulatory, and manufacturing work carried out by Zydus teams. Additionally, ZITUVIO has been rigorously tested for Nitrosamines and potential genotoxic impurities, adhering to the stringent current USFDA standards. The product is completely compliant with the present-day USFDA regulations concerning Nitrosamines in Sitagliptin-containing products.

ZITUVIO by Zydus gets green light from FDA: A new milestone in diabetes management. Photo courtesy of Zydus Cadila.

Leadership’s Take on the Approval

Reflecting on this significant achievement, Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, shared, “The ZITUVIOTM approval builds on Zydus’ long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management.”

Dr. Punit Patel, CEO of Zydus Pharmaceuticals- Americas, added, “We are pleased to be able to receive such a milestone approval for Zydus… We look forward to bringing additional innovative products in the future that align with our purpose to empower patients to live healthier and more fulfilled lives.”

Market Scope for DPP-IV Inhibitors

According to data from IQVIA (MAT Aug-2023), the current U.S. market valuation for DPP-IV inhibitors, along with their combinations, stands at a staggering $10 billion.