Farxiga FDA Approval History
Last updated by Judith Stewart, BPharm on June 17, 2024.
FDA Approved: Yes (First approved January 8, 2014)
Brand name: Farxiga
Generic name: dapagliflozin
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Type 2 Diabetes, 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 and children aged 10 years and older 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
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.