Reata Granted Pre-NDA Meeting for Omaveloxolone

Reata Granted Pre-NDA Meeting for Omaveloxolone

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Reata Granted Pre-NDA Meeting for Omaveloxolone

Reata Pharmaceuticals has been granted a preliminary meeting with the U.S. Food and Drug Administration (FDA) to discuss the submission of a new drug application (NDA) for omaveloxolone, an investigational treatment for Friedreich’s ataxia (FA). According to a company press release, the pre-NDA meeting is scheduled to take place during the third quarter of this year and briefing materials for review have been submitted. Reata expects to submit the NDA for omaveloxolone at the beginning…

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