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Invokana FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

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:

Development timeline for Invokana

DateArticle
Sep 30, 2019Approval FDA 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, 2018Approval FDA 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, 2013Approval FDA 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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