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Jardiance FDA Approval History

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 with Reduced Ejection Fraction

Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor for the treatment of type 2 diabetes, to reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease, and to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.

Development Timeline for Jardiance

DateArticle
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

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