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Farxiga FDA Approval History

Last updated by Judith Stewart, BPharm on May 17, 2023.

FDA Approved: Yes (First approved January 8, 2014)
Brand name: Farxiga
Generic name: dapagliflozin
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Diabetes, Type 2, Heart Failure, Chronic Kidney Disease

Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor for use in the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease.

  • Farxiga is indicated:
    • 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.
    • to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
    • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
    • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Farxiga contains dapagliflozin which belongs to the class of drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.
  • Farxiga tablets are taken orally once daily.
  • Warnings and precautions associated with Farxiga include ketoacidosis in patients with diabetes mellitus, volume depletion, urosepsis and pyelonephritis, hypoglycemia, necrotizing fasciitis of the perineum (Fournier’s Gangrene), and genital mycotic infections.
  • Common adverse reactions include female genital mycotic infections, nasopharyngitis, and urinary tract infections.

Development timeline for Farxiga

DateArticle
May  9, 2023Approval Farxiga Extended in the US to Reduce Risk of Cardiovascular Death and Hospitalisation for Heart Failure to a Broader Range of Patients
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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