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
Further information
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