FDA OKs Zogenix’s Fintepla for Dravet syndrome

Under Priority Review status, the FDA has accepted Zogenix’s (NASDAQ:ZGNX) NDA for FINTEPLA (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet syndrome.

PDUFA target action date is March 25, 2020.

The FDA is currently not planning to hold an advisory committee meeting to discuss the application for FINTEPLA.

Shares are up 1% premarket.

https://seekingalpha.com/news/3521752-fda-oks-zogenixs-fintepla-dravet-syndrome