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Jardiance FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 17, 2022.

FDA Approved: Yes (First approved August 1, 2014)
Brand name: Jardiance
Generic name: empagliflozin
Dosage form: Tablets
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction, Heart Failure

Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor used for the treatment of type 2 diabetes; and to reduce the risk of cardiovascular death in patients with heart failure, and type 2 diabetes patients with established cardiovascular disease.

Jardiance is indicated:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
  • to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Development timeline for Jardiance

Nov  4, 2022EMPA-KIDNEY trial showed significant benefit of Jardiance in reducing kidney disease progression or cardiovascular death in people with chronic kidney disease
Feb 25, 2022Approval US FDA Approves Jardiance (empagliflozin) to Treat Adults with Heart Failure Regardless of Left Ventricular Ejection Fraction
Aug 18, 2021Approval FDA Approves Jardiance (empagliflozin) to Treat Adults Living with Heart Failure with Reduced Ejection Fraction
Dec  2, 2016Approval FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes
Aug  1, 2014Approval FDA Approves Jardiance (empagliflozin) to Treat Type 2 Diabetes
Jun 17, 2014Boehringer Ingelheim and Eli Lilly and Company Announce Resubmission of NDA for Empagliflozin to FDA
Mar  5, 2014U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin
Mar 29, 2013Boehringer Ingelheim, Lilly Submit NDA for Empagliflozin

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.