Tentative FDA approval for two Zydus generics

15 February 2023

Indian generics major Zydus Lifesciences (NYSE: ZYDUSLIFE) has received tentative approval from the US Food and Drug Administration (FDA) to market canagliflozin tablets, 100mg and 300mg.

Canagliflozin is the active ingredient of Johnson & Johnson’s (NYSE: JNJ Invokana. It 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 Indian group’s formulation manufacturing facility at Moraiya.

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