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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

Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Development Timeline for Jardiance

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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