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# FDA Extends Review of Reata Pharma NDA
- URL: https://www.fdaweb.com/fda-extends-review-of-reata-pharma-nda/
- Published: 2022-08-09T12:00:00.000Z
- Updated: 2026-09-14T17:55:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152466

A day after updating investors that the company had submitted additional data to FDA to support its efficacy data in a recent NDA for omaveloxolone, indicated for treating patients with Friedreich’s ataxia, Reata Pharmaceuticals now says the agency notified it that the submission’s review is being extended by three months. The data submission is intended to ease FDA scrutiny of the NDA’s “strength” of efficacy evidence, according to the company ([see earlier story](https://www.fdaweb.com/reata-faces-fda-efficacy-scrutiny-on-omaveloxolone/)).

The revised user fee review action date is 2/28/2023\. Additionally, an FDA-planned advisory committee meeting is on hold pending review of the new NDA amendments, according to Reata.