Reata Accepts FDA’s Suggestion of Pre-NDA Meeting for Omaveloxolone

Reata Accepts FDA’s Suggestion of Pre-NDA Meeting for Omaveloxolone

294639

Reata Accepts FDA’s Suggestion of Pre-NDA Meeting for Omaveloxolone

The U.S. Food and Drug Administration (FDA) has asked Reata Pharmaceuticals to request a preliminary meeting to discuss submitting a new drug application (NDA) for omaveloxolone, an investigational therapy for Friedreich’s ataxia (FA). Reata was due to hold a Type C meeting (unrelated to NDA requests) with the FDA’s Division of Neurology Products 1, but the division determined that, after reviewing the company’s Type C meeting briefing material, a pre-NDA meeting was more appropriate. “We welcome…

You must be logged in to read/download the full post.