FDA Approves First Generic Versions of FARXIGA
Agency approves multiple dapagliflozin generics to reduce heart failure hospitalization risk and improve glycemic control in adults with type 2 diabetes
By
Kathryn Wighton
April 7, 2026
Clinical Scorecard: FDA Approves First Generic Versions of FARXIGA
At a Glance
Category Detail
Condition Type 2 Diabetes Mellitus Key Mechanisms Sodium-glucose cotransporter 2 inhibitor that reduces glucose and sodium reabsorption in the kidneys. Target Population Adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. Care Setting Outpatient
Key Highlights
First generic versions of FARXIGA (dapagliflozin) approved by FDA. Indicated for reducing hospitalization risk for heart failure and improving glycemic control. Contraindicated in patients with prior serious hypersensitivity to dapagliflozin. Common adverse events include genital infections, nasopharyngitis, and urinary tract infections. Healthcare providers should consult the Orange Book for approved products. Guideline-Based Recommendations
Diagnosis
Diagnosis of type 2 diabetes mellitus typically in adults. Management
Use dapagliflozin as an adjunct to diet and exercise for glycemic control. Monitoring & Follow-up
Monitor for signs of diabetic ketoacidosis and volume depletion. Risks
Risk of diabetic ketoacidosis, particularly in type 1 diabetes patients. Patient & Prescribing Data
Adults with type 2 diabetes and cardiovascular risk factors.
Prescribing information consistent with branded product, including contraindications and precautions.
Clinical Best Practices
Review full prescribing information for safety and dosing guidance. Consult the Orange Book for therapeutic equivalence evaluations. Educate patients on potential adverse effects and signs of complications. References
