www.fdanews.com/articles/175026-zogenix-scoops-up-fda-fast-track-status-for-zx008
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Zogenix Scoops Up FDA Fast Track Status for ZX008
January 25, 2016
The FDA has fast tracked Zogenix’s ZX008 to treat seizures associated with Dravet syndrome, a rare form of childhood epilepsy.
The designation qualifies Zogenix for more communication with the agency and a potentially quicker review and approval process. Zogenix notes that a second Phase 3 study of ZX008 will begin in Europe this quarter.