Posted by Michael Wonder on 20 Sep 2021
Marinus Pharmaceuticals announces FDA acceptance for filing and priority review of new drug application for ganaxolone in CDKL5 deficiency disorder
20 September 2021 - FDA indicated that it is not currently planning to hold an advisory committee meeting for the application.
Marinus Pharmaceuticals today announced that the U.S. FDA accepted for filing the company’s new drug application for the use of ganaxolone in the treatment of seizures associated with CDKL5 deficiency disorder, a rare, genetic epilepsy.
The new drug application was granted priority review designation and the FDA assigned a Prescription Drug User Fee Act action date of 20 March 2022.
