Posted by Michael Wonder on 21 Jun 2022
Acer Therapeutics and Relief Therapeutics announce update on U.S. FDA review of new drug application for ACER-001
21 June 2022 - Citing the need to inspect a third-party contract packaging manufacturer, the U.S. FDA has issued a complete response letter.
Acer Therapeutics and its collaboration partner, Relief Therapeutics, announced today that the U.S. FDA has issued a complete response letter regarding the new drug application for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders.
