28 September 2021 - Supplemental new drug application submission is supported by existing clinical data, including positive data from Company’s Phase 3 trial, Study 1601, in which the primary outcome was met with high statistical significance.
Zogenix today announced that it has submitted a supplemental new drug application for Fintempla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome to the U.S. FDA.