FDA Approves Extended-Release Dapagliflozin-Metformin Combination
October 30, 2014 – AstraZeneca received FDA approval for Xigduo™ XR, an extended-release combination of dapagliflozin and metformin for the treatment of adults with type 2 diabetes. Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor (marketed in the U.S. as Farxiga™), obstructs the reabsorption of glucose in the kidneys, causing more glucose to be lost in urine. Metformin decreases glucose production and increases glucose utilization, further reducing the amount of glucose in the blood.
Xigduo XR is recommended to be taken once a day to treat adults with type 2 diabetes. It should be used in tandem with diet changes and exercise. It is not indicated for patients with type 1 diabetes, diabetic ketoacidosis or kidney failure. Xigduo XR has a boxed warning label advising that, in rare cases, the metformin component may cause lactic acidosis, a potentially dangerous accumulation of too much acid in the body. Launch and pricing information for Xigduo XR are not yet available.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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