U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
Dublin, Ireland-based Avadel Pharma announced positive topline data from the company’s pivotal Phase III REST-ON clinical trial of FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy.
An investigational medicine in late-stage development by Jazz Pharmaceuticals hit the mark in treating cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy.
A U.S. appeals court ruled invalid patents owned by Jazz Pharmaceuticals covering the company’ narcolepsy drug Xyrem, opening the door for Amneal Pharmaceuticals to launch a generic version of the medicine.
The U.S. Food and Drug Administration approved the first generic version of Xyrem, Jazz Pharmaceuticals Plc’s drug to treat patients with narcolepsy, a kind of sleeping disorder.