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Invokana FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Sep 30, 2019.

FDA Approved: Yes (First approved March 29, 2013)
Brand name: Invokana
Generic name: canagliflozin
Dosage form: Tablets
Company: Janssen Research & Development, LLC
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction, Diabetic Kidney Disease

Invokana (canagliflozin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor indicated:

  • along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
  • to reduce the risk of major cardiovascular events in adults with type 2 diabetes who have known cardiovascular disease
  • to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine.

Development Timeline for Invokana

Sep 30, 2019ApprovalFDA Approves Invokana (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes and DKD
Oct 30, 2018ApprovalFDA Approves Invokana (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
Mar 29, 2013ApprovalFDA Approves Invokana to Treat Type 2 Diabetes
Jan 11, 2013FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of Adults with Type 2 Diabetes
May 31, 2012Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes

Further information

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