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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
Company: AstraZeneca
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.

Indications

  • 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

DateArticle
Apr 30, 2021Approval  Farxiga Approved in the US for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type-2 Diabetes
May  6, 2020Approval  Farxiga Approved in the US for the Treatment of Heart Failure in Patients with Heart Failure with Reduced Ejection Fraction
Apr 23, 2020AstraZeneca and Saint Luke’s Mid America Heart Institute Initiate Phase III DARE-19 Trial with Farxiga in COVID-19 Patients
Oct 21, 2019Approval  FDA Approves Farxiga (dapagliflozin) to Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes
Jan  8, 2014Approval  FDA Approves Farxiga to Treat Type 2 Diabetes
Dec 12, 2013FDA Advisory Committee Recommends the Investigational SGLT2 Inhibitor Dapagliflozin for Treatment of Type 2 Diabetes in Adults
Jul 25, 2013AstraZeneca and Bristol-Myers Squibb resubmit Dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S
Jan 19, 2012Bristol-Myers Squibb and AstraZeneca Receive Complete Response Letter from U.S. Food and Drug Administration for Dapagliflozin
Oct 27, 2011U.S. Food and Drug Administration Extends Action Date for Dapagliflozin by Three Months
Jul 20, 2011FDA Advisory Committee Makes Recommendation on Investigational Compound Dapagliflozin
Mar  8, 2011FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the Treatment of Type 2 Diabetes

Further information

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