Farxiga Approval History

  • FDA approved: Yes (First approved January 8th, 2014)
  • Brand name: Farxiga
  • Generic name: dapagliflozin
  • Company: Bristol-Myers Squibb Company and AstraZeneca
  • Treatment for: Diabetes, Type 2

Farxiga (dapagliflozin) is a selective sodium-glucose cotransporter-2 inhibitor for the treatment of adults with type 2 diabetes mellitus.

FDA Approval History for Farxiga

DateArticle
Jan  8, 2014Approval FDA Approves Farxiga to Treat Type 2 Diabetes
Dec 12, 2013FDA Advisory Committee Recommends the Investigational SGLT2 Inhibitor Dapagliflozin for Treatment of Type 2 Diabetes in Adults
Jul 25, 2013AstraZeneca and Bristol-Myers Squibb resubmit Dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S
Jan 19, 2012Bristol-Myers Squibb and AstraZeneca Receive Complete Response Letter from U.S. Food and Drug Administration for Dapagliflozin
Oct 27, 2011U.S. Food and Drug Administration Extends Action Date for Dapagliflozin by Three Months
Jul 20, 2011FDA Advisory Committee Makes Recommendation on Investigational Compound Dapagliflozin
Mar  8, 2011FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the Treatment of Type 2 Diabetes

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