Zydus Lifesciences bags tentative USFDA nod for Canagliflozin Tablets

Ahmedabad: Pharma major, 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.

Medical Dialogues team had earlier reported that Zydus Lifesciences Limited had received final approval from the USFDA to market Silodosin Capsules, 4 mg and 8 mg (USRLD: Rapaflo capsules).

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