Zydus has obtained the Food and Drug Administration’s blessing for Zituvio (sitagliptin) tablets, 25 mg, 50 mg and 100 mg.
Sitagliptin 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 Zituvio approval builds on Zydus' long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management," said Sharvil Patel, managing director of Zydus Lifesciences Limited.
"We are pleased to be able to receive such a milestone approval for Zydus. Through our industry leading capabilities, we pride ourselves in finding innovative ways to bring value to the healthcare systems by providing affordable medicines for our patients. 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," said Punit Patel, CEO of Zydus Pharmaceuticals, Americas.
According to IQVIA August 2023 data, the U.S. market for DPP-IV inhibitors and its combinations is $10 billion.