Zydus Lifesciences gets USFDA’s tentative approval for Canagliflozin Tablets

15 Feb 2023 Evaluate

Zydus Lifesciences 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 $660 million in the United States (IQVIA MAT December 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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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