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The approval was announced by Zydus Life Sciences Limited in a press release on October 20, 2023.
The US Food and Drug Administration has approved a New Drug Application from Zydus Life Sciences Limited for sitagliptin (Zituvio) tablets as an adjunct to diet and exercise to diet and exercise for improving glycemic control in people with type 2 diabetes.
Announced by Zydus Lifesciences Limited, an India-based company with a portfolio of generic medications, on October 20, 2023, includes sitagliptin tablets in 25 mg, 50 mg, and 100 mg formulations.1
"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, chief executive officer of Zydus Pharmaceuticals, Americas.1
According to Zydus Life Sciences Limited the approval is based on research, development, regulatory and manufacturing work performed by teams within their company and sitagliptin ZITUVIO™ has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current regulatory standards. The company also noted the approved agent is compliant with current regulatory standards of nitrosamines in sitagliptin containing products.1
The initial FDA approval for sitagliptin came in October 2006 when the agent received approval for as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. This approval, which was awarded to Merck and Co., marked the first approval for a DPP-4 inhibitor.2 Since the approval of sitagliptin, the use of DPP-4 inhibitors has increased significantly, with Zydus Life Sciences Limited estimating the US market for DPP-4 inhibitors and its combinations is approximately $10 billion.1
In their release, Zydus Life Sciences Limited pointed out sitagliptin is not recommend in patients with type 1 diabetes mellitus, had not been studied in patients with a history of pancreatitis, and is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin or any of the excipients in ZITUVIO™, such as anaphylaxis or angioedema.1
"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.1
Zydus Lifesciences Limited. Zydus receives US FDA approval for ZITUVIOTM to treat adult patients with type 2 diabetes mellitus. PR Newswire: press release distribution, targeting, monitoring and marketing. October 20, 2023. Accessed October 20, 2023. https://www.prnewswire.com/news-releases/zydus-receives-usfda-approval-for-zituvio-to-treat-adult-patients-with-type-2-diabetes-mellitus-301963298.html.
Gallwitz B. Clinical Use of DPP-4 Inhibitors. Front Endocrinol (Lausanne). 2019;10:389. Published 2019 Jun 19. doi:10.3389/fendo.2019.00389