Jardiance FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 24, 2023.
FDA Approved: Yes (First approved August 1, 2014)
Brand name: Jardiance
Generic name: empagliflozin
Dosage form: Tablets
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Type 2 Diabetes, Cardiovascular Risk Reduction, Heart Failure, Chronic Kidney Disease
Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor used for cardiovascular risk reduction, heart failure, chronic kidney disease, and type 2 diabetes.
- 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 sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.
- 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 and pediatric patients aged 10 years and older with type 2 diabetes mellitus. - Jardiance contains empagliflozin which is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions such as lowering both pre- and afterload of the heart and downregulating sympathetic activity.
- Jardiance tablets are taken orally once daily in the morning, with or without food.
- Warnings and precautions associated with Jardiance include ketoacidosis, volume depletion, urosepsis and pyelonephritis, hypoglycemia, necrotizing fasciitis of the perineum (Fournier’s Gangrene), genital mycotic infections, and hypersensitivity reactions.
- Common adverse reactions include urinary tract infections and female genital mycotic infections.
Development timeline for Jardiance
Further information
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