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: Type 2 Diabetes, 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 and pediatric patients aged 10 years and older 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 or multiple cardiovascular 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 eGFR decline, end-stage kidney disease, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
  Limitations of use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
  Because of the metformin HCl component, the use of Xigduo XR is limited to patients with type 2 diabetes mellitus for all indications.
  Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease. Xigduo XR is not expected to be effective in these populations.

Development timeline for Xigduo XR

Further information

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