Posted by Michael Wonder on 09 Aug 2022
Reata Pharmaceuticals announces three month extension of the review period for new drug application for omaveloxolone for the treatment of Friedreich’s ataxia
9 August 2022 - PDUFA date extended to 28 February 2023.
Reata Pharmaceuticals announced that on 8 August 2022, after the U.S. financial markets closed, we received a communication from the U.S. FDA informing us that they have extended the review timeline for the new drug application for omaveloxolone for the treatment of Friedreich’s ataxia by three months.
