Posted by Michael Wonder on 18 Jul 2022
Relief Therapeutics announces that its collaboration partner has resubmitted the ACER-001 (sodium phenylbutyrate) new drug application to the FDA for the treatment of urea cycle disorders
18 July 2022 - Relief Therapeutics today announced that its collaboration partner, Acer Therapeutics for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders, has resubmitted its new drug application for ACER-001 to the U.S. FDA.
Relief has been advised by Acer that it believes that the resubmission addresses, in full, the items raised by the FDA in the complete response letter.
