Application Nr Approved Date Route Status External Links
NDA204042 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Invokana ® (Canagliflozin) Is Indicated: As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. To Reduce The Risk Of Major Adverse Cardiovascular Events (Cardiovascular Death, Nonfatal Myocardial Infarction And Nonfatal Stroke) In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease (Cvd). To Reduce The Risk Of End-Stage Kidney Disease (Eskd), Doubling Of Serum Creatinine, Cardiovascular (Cv) Death, And Hospitalization For Heart Failure In Adults With Type 2 Diabetes Mellitus And Diabetic Nephropathy With Albuminuria > 300 Mg/day. Invokana 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 ( 1 ) To Reduce The Risk Of Major Adverse Cardiovascular Events In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease ( 1 ) To Reduce The Risk Of End-Stage Kidney Disease, Doubling Of Serum Creatinine, Cardiovascular Death, And Hospitalization For Heart Failure In Adults With Type 2 Diabetes Mellitus And Diabetic Nephropathy With Albuminuria ( 1 ). Limitations Of Use: Not For Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis ( 1 ) Limitations Of Use Invokana Is Not Recommended In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Diabetic Ketoacidosis.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Canagliflozin CANAGLIFLOZIN ZINC43207238

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