Application Nr Approved Date Route Status External Links
NDA202293 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Farxiga Is A Sodium-Glucose Cotransporter 2 (Sglt2) Inhibitor Indicated In Adults For: Type 2 Diabetes Mellitus: • As An Adjunct To Diet And Exercise To Improve Glycemic Control. (1.1) • To Reduce The Risk Of Hospitalization For Heart Failure In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease Or Multiple Cardiovascular Risk Factors. (1.1) Heart Failure: • To Reduce The Risk Of Cardiovascular Death And Hospitalization For Heart Failure In Adults With Heart Failure With Reduced Ejection Fraction (Nyha Class Ii-Iv). (1.2) Limitations Of Use : • Not For Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis. (1.3) 1.1 Type 2 Diabetes Mellitus Farxiga (Dapagliflozin) 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 Hospitalization For Heart Failure In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease (Cvd) Or Multiple Cardiovascular (Cv) Risk Factors. 1.2 Heart Failure Farxiga Is Indicated To Reduce The Risk Of Cardiovascular Death And Hospitalization For Heart Failure In Adults With Heart Failure (Nyha Class Ii-Iv) With Reduced Ejection Fraction. 1.3 Limitations Of Use Farxiga Is Not Recommended For 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. Dapagliflozin Propanediol

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