Zydus Lifesciences Gets USFDA Nod for Diabetes Drug - Zituvimet XR
Jul 19, 2024 12:16
Zydus Lifesciences receives USFDA approval for its new drug application for Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets, a diabetes medication. This marks the company's third NDA approval for the Sitagliptin franchise.
New Delhi, Jul 19 (PTI) Zydus Lifesciences on Friday said it has received approval from the US health regulator for its new drug application for a diabetes medication.
The company has received final approval for its new drug application (NDA) from the US Food and Drug Administration (USFDA) to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets, the drug firm said in a statement.
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.
Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The product will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, Zydus Lifesciences said.
According to IQVIA (MAT May 2024), the US market for DPP-IV inhibitors (oral diabetes medications) and its combinations stood at USD 9.5 billion.
Shares of Zydus Lifesciences were trading 2.04 per cent down at Rs 1,161.10 apiece on the BSE.
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