Zydus Lifesciences secures USFDA approval for Zituvimet XR

22 Jul 2024 , 09:38 AM

Zydus Lifesciences announced that it has received final approval from the US Food and Drug Administration (USFDA) for its new drug application (NDA) for a diabetes medication.

The approval is for Zituvimet XR, which consists of sitagliptin and metformin hydrochloride in extended-release tablet form.

Zituvimet XR is intended as an adjunct to diet and exercise to help improve glycemic control in adults with type 2 diabetes mellitus. This approval marks a significant milestone as Zydus now has all three NDAs of the Sitagliptin (base) and combination franchise approved.

At the time of writing on July 22, 2024 at 9:36 am shares of Zydus Lifesciences is  currently trading at ₹1160 which is a 1.42% dip than the previous close. Zydus Lifesciences stock has gained a total of 89% in the last one year, and witnessed a 66% gain since the beginning of the year.

Impressively, all three NDAs achieved first-cycle approval (FCA), indicating a smooth and efficient review process by the USFDA. Zituvimet XR will be manufactured at Zydus Lifesciences’ formulation manufacturing facility located in Ahmedabad SEZ.

According to data from IQVIA (MAT May 2024), the US market for DPP-IV inhibitors (oral diabetes medications) and their combinations is valued at approximately USD 9.5 billion.

Zydus Lifesciences, formerly known as Cadila Healthcare Limited, is a prominent Indian multinational pharmaceutical company based in Ahmedabad. The company, Zydus Lifesciences is primarily engaged in the manufacturing of generic drugs and has established a strong presence in the healthcare sector through its innovative product portfolio.

Zydus Lifesciences continues to contribute significantly to global healthcare by developing and marketing high-quality pharmaceutical products. The approval of Zituvimet XR is expected to enhance Zydus’ market presence in the US diabetes medication segment and contribute to the company’s growth.

The company’s consistent focus on research and development, along with its robust manufacturing capabilities, underscores its commitment to delivering effective healthcare solutions.