Jazz Pharmaceuticals Announce the FDA Acceptance of New Drug Application for JZP-258
Jazz Pharmaceuticals plc announced that the US Food and Drug Administration (FDA) accepted for filing with Priority Review the company’s New Drug Application seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
According to a press release sent out by Jazz Pharmaceuticals, JZP-258 is a novel oxybate product with a unique composition of cations resulting in 92%, or approximately 1,000 to 1,500 milligrams, less sodium than Xyrem® (sodium oxybate). Xyrem is the only available product approved to treat both cataplexy and excessive daytime sleepiness in patients with narcolepsy ages 7 years and older.
Read the full press release here.
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Date Created: March 27th, 2020
Last Updated: December 8th, 2020