Zydus Lifesciences Limited announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Canagliflozin Tablets, 100 mg and 300 mg, via an exchange filing.
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.
