Breaking News: Zydus Lifesciences Receives USFDA Approval for New Diabetes Drug

Zydus Lifesciences has announced that its new drug application (NDA) for a diabetes medication has been approved by the US Food and Drug Administration (USFDA).

The approved drug, Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets, is intended to help adults with type 2 diabetes mellitus manage their blood sugar levels when combined with diet and exercise. This approval means that Zydus now has all three NDAs of the Sitagliptin (base) and combination franchise approved, with all receiving first-cycle approval (FCA).

The US market for DPP-IV inhibitors (oral diabetes medications) and their combinations is valued at USD 9.5 billion, according to IQVIA (MAT May 2024). Despite this positive development, shares of Zydus Lifesciences were down 2.04 percent, trading at Rs 1,161.10 each on the BSE.