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: Johnson & Johnson Innovative Medicine
Treatment for: Type 2 Diabetes, 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

Date	Article
Sep 30, 2019	Approval 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, 2018	Approval 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, 2013	Approval FDA Approves Invokana to Treat Type 2 Diabetes
Jan 11, 2013	FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of Adults with Type 2 Diabetes
May 31, 2012	Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA