Posted by Michael Wonder on 27 Aug 2024
Soleno Therapeutics announces US FDA acceptance for filing and priority review of NDA for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
27 August 2024 - Soleno Therapeutics today announced that the US FDA has accepted for filing its new drug application for DCCR for the treatment of Prader-Willi syndrome in individuals four years and older who have hyperphagia.
The FDA granted priority review for the NDA and assigned a PDUFA target action date of 27 December 2024.
