Tags : fenfluramine

Regulatory

Zogenix Reports the US FDA Acceptance of NDA and Granted

Shots: The NDA is based on two P-III studies and an interim analysis from an ongoing OLE study which includes assessing Zogenix in 232 patients with Dravet syndrome for up to 21mos. The two P-III study resulted in meeting 1EPs and all 2EPs. Additionally, Zogenix is also investigating Fintepla in Lennox-Gastaut syndrome in P-III study […]Read More