Zydus Lifesciences bags USFDA approval for type 2 diabetes mellitus drug Zituvio for adults
Ahmedabad: Zydus Lifesciences Limited has announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for ZITUVIO (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.
ZITUVIO contains active ingredient Sitagliptin, 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.
"The ZITUVIO approval builds on Zydus' long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management," said Dr. 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 Dr. Punit Patel, CEO of Zydus Pharmaceuticals, Americas.
According to IQVIA (MAT Aug-2023), U.S. market for DPP-IV inhibitors and its combinations is US$ 10 bn.
Read also: Zydus ropes in Punit Patel as President, CEO to lead business operations in North America
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The Company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.
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