Zydus Lifesciences gain on US FDA approval for diabetic drug

Zydus Lifesciences on October 20 announced that the USFDA approved its New Drug Application (NDA) for ZITUVIOTM (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, company said in its statement.

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Shares of Zydus Lifesciences gained nearly a percent in the early trade on October 23 after the company received the US Food and Drug Administration (USFDA) approval for its diabetes drug.

At 9:18am, Zydus Lifesciences was quoting Rs 582.20, up Rs 3.65, or 0.63 percent, on the BSE.

The company on October 20 announced that the USFDA had approved its New Drug Application (NDA) for Zituviotm (Sitagliptin) tablets of 25mg, 50mg, and 100mg strength in a statement.

Zituviotm 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, it added.

The drug has undergone quality testing for nitrosamines and potential genotoxic impurities as per the current US FDA standards. Zituviotm is compliant with the current USFDA standards of nitrosamines in sitagliptin containing products.

“The Zituviotm 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.

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Last week, the company appointed of Punit Patel as president and chief executive officer for Americas. Patel will be responsible for the business operations of all Zydus entities in North America that would cover generics, injectables and specialty business, rare and orphan disease portfolio, and also future forays into novel therapeutics.

Earlier in this month, the company had received the final approval from the US FDA for sugammadex injection, a post-surgery drug, which is used to reverse the effect of muscle relaxants such as rocuronium and vecuronium in adults undergoing surgery.