Zydus gets final approval from US FDA for Type 2 diabetes pills

Ahmedabad, July 19 – Indian pharma company Zydus Lifesciences on Friday said that it has received final approval from the US Food and Drug Administration (USFDA) to market tablets for Type 2 diabetes.

The drugmaker said it got “approval for its New Drug Application (NDA) to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets”.

With this, Zydus has all three NDAs of Sitagliptin (base) and combination franchise approved, it added.

“Notably, all the three NDAs achieved first-cycle approval (FCA),” the company stated.

Further, it added that the product will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.

According to IQVIA (MAT May 2024), the US market for DPP-IV inhibitors and its combinations is $9.5 bn.