Posted by Michael Wonder on 01 Aug 2019
Eton Pharmaceuticals announces FDA acceptance of new drug application for ET-105
1 August 2019 - ET-105 assigned Prescription Drug User Fee Act target action date of 17 March 2020.
Eton Pharmaceuticals today announced that Aucta Pharmaceuticals' New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, has been accepted for review by the U.S. FDA.
ET-105 is a patent-pending formulation of lamotrigine, for which Aucta is seeking approval as an adjunct therapy for partial seizures, primary generalised tonic-clonic seizures, and generalised seizures of Lennox-Gastaut syndrome in patients two years of age and older.
