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# FDA Extends Review of Invokana Supplemental NDA
- URL: https://www.fdaweb.com/fda-extends-review-of-invokana-supplemental-nda/
- Published: 2018-07-16T12:00:00.000Z
- Updated: 2026-09-15T00:19:39.000Z
- Author: David McFarland
- Tags: EIRs/483s, FDA Policy/General, #legacy-id-D5141882

FDA has extended by three months the review of a Janssen Pharmaceutical Companies supplemental NDA for Invokana (canagliflozin), indicated for reducing the risk of major adverse cardiovascular events in adults with Type 2 diabetes who have established cardiovascular disease or are at risk for the disease. The submission also applies to Invokana fixed-dose combinations, Invokamet and Invokamet XR, and is based on [data](https://www.jnj.com/media-center/press-releases/invokana-canagliflozin-significantly-reduces-the-combined-risk-of-cardiovascular-death-myocardial-infarction-and-stroke-in-the-canvas-program?ref=fdaweb.com) from the Phase 3 CANVAS program. The agency extended the review to assess additional analyses requested from the company. The review action date is now expected in October, Janssen says.