Posted by Michael Wonder on 28 Jul 2022
Acer Therapeutics and Relief Therapeutics announce FDA acceptance for review of NDA resubmission for ACER-001 for treatment of UCDs
28 July 2022 - Prescription Drug User Fee Act target action date set for 15 January 2023.
Acer Therapeutics and its collaboration partner Relief Therapeutics, today announced the U.S. FDA has accepted for review Acer’s resubmitted new drug application for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders.
