Drug Approval
Zydus receives tentative approval from the USFDA for Canagliflozin tablets
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya
- By IPP Bureau
| February 16, 2023
Zydus Lifesciences Limited 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).
