Farxiga FDA Approval History
Last updated by Judith Stewart, BPharm on May 3, 2021.
FDA Approved: Yes (First approved January 8, 2014)
Brand name: Farxiga
Generic name: dapagliflozin
Dosage form: Tablets
Treatment for: Diabetes, Type 2, Renal Failure, Heart Failure
Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease.
- Type 2 Diabetes Mellitus
- as an adjunct to diet and exercise to improve glycemic control in adults.
- 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.
- 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).
- Chronic Kidney Disease
- to reduce the risk of sustained eGFR decline, end stage kidney disease cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
Development Timeline for Farxiga
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