Posted by Michael Wonder on 04 Dec 2024
Soleno Therapeutics announces FDA extension of review period for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
26 November 2024 - PDUFA target action date extended by three months to 27 March 2025.
Soleno Therapeutics today announced that the US FDA has extended the review period for the new drug application for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome in individuals four years and older who have hyperphagia.
