Xigduo XR FDA Approval History
FDA Approved: Yes (First approved October 30, 2014)
Brand name: Xigduo XR
Generic name: dapagliflozin and metformin hydrochloride
Dosage form: Extended-Release Tablets
Company: AstraZeneca
Treatment for: Diabetes, Type 2, Heart Failure
Xigduo XR (dapagliflozin and metformin hydrochloride) is a once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.
- Xigduo XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dapagliflozin is indicated to reduce:
- the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
- the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.
- the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
Development timeline for Xigduo XR
| Date | Article |
|---|---|
| Oct 30, 2014 | Approval FDA Approves Xigduo XR (dapagliflozin and metformin hydrochloride) for Type 2 Diabetes |
Further information
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