Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received final approval for its New Drug Application (NDA) from the United States Food and Drug Administration (USFDA) 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 through the 505(b)(2) route. Notably, all the three NDAs achieved First-Cycle Approval (FCA).
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, India.
According to IQVIA (MAT May 2024), U.S. market for DPP-IV inhibitors and its combinations is US$ 9.5 bn.
Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 1144.60 as compared to the previous close of Rs. 1185.30. The total number of shares traded during the day was 105145 in over 4403 trades.
The stock hit an intraday high of Rs. 1168.75 and intraday low of 1137.90. The net turnover during the day was Rs. 121895208.00. |
