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Jazz Pharmaceuticals Announce the FDA Acceptance of New Drug Application for JZP-258

March 27th, 2020

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 21st, 2023