Zydus receives tentative approval from the USFDA for Canagliflozin Tablets

Zydus Lifesciences Limited (including its subsidiaries / affiliates hereafter referred to as "Zydus") has received tentative approval from the United States Food and Drug Administration (USFDA) to market Canagliflozin Tablets, 100 mg and 300 mg (USRLD: Invokana® Tablets).

Canagliflozin Tablet is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The drug will be manufactured at the group's formulation manufacturing facility at Moraiya. Canagliflozin Tablets had annual sales of USD 660 mn in the United States (IQVIA MAT Dec. 2022).

The group now has 341 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

(*as of 31st December 2022)

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 469.20 as compared to the previous close of Rs. 472.85. The total number of shares traded during the day was 60713 in over 1159 trades.

The stock hit an intraday high of Rs. 474.70 and intraday low of 466.20. The net turnover during the day was Rs. 28416784.00.

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 TentativeApproval USFDA CanagliflozinTablets