Posted by Michael Wonder on 29 Jun 2024
Soleno Therapeutics announces submission of new drug application to the US FDA for diazoxide choline extended-release tablets for the treatment of Prader-Willi syndrome
28 June 2024 - Soleno Therapeutics today announced the submission of a n ew drug application to the US FDA for approval diazoxide choline extended-release tablets for the treatment of Prader-Willi syndrome in individuals four years and older who have hyperphagia.
Diazoxide choline has breakthrough and fast track designations in the US, as well as orphan drug designation for Prader-Will syndrome in the US and EU.
