Objective:

To announce the approval of the first generic versions of dapagliflozin for reducing hospitalization risk for heart failure in adults with type 2 diabetes and for improving glycemic control as an adjunct to diet and exercise.

Key Findings:

• Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor.
• It is used for adults with type 2 diabetes and cardiovascular risk factors.
• The generic products have the same prescribing information as the branded version.
• More than 40 million Americans have diabetes, with approximately 90% to 95% classified as type 2 diabetes.

Interpretation:

The approval of generic dapagliflozin may increase accessibility and affordability for patients with type 2 diabetes.

Limitations:

• Use is contraindicated in patients with prior serious hypersensitivity to dapagliflozin.
• Safety concerns include diabetic ketoacidosis and other related events, with common adverse events including female genital mycotic infections, nasopharyngitis, and urinary tract infections.

Conclusion:

The introduction of generic dapagliflozin offers a new option for managing type 2 diabetes and associated cardiovascular risks, potentially increasing accessibility and affordability for patients.