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 inhibitorsDPP-IV inhibitors and its combinations is US$ 10 bn.
The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 25000 people worldwide and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through pathbreaking discoveries. For more details visit www.zyduslife.com.
Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of ZITUVIO™ in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms.
Acute Renal Failure: Has been reported post marketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating ZITUVIO™ and periodically thereafter.
Severe and Disabling Arthralgia: Has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
Bullous Pemphigoid: There have been post marketing reports requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue ZITUVIO™.
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