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# Priority Review for Jazz Xyrem sNDA
- URL: https://www.fdaweb.com/priority-review-for-jazz-xyrem-snda/
- Published: 2018-06-27T12:00:00.000Z
- Updated: 2026-09-15T00:16:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141787

FDA has accepted for priority review a Jazz Pharmaceuticals supplemental NDA seeking revised labeling for Xyrem (sodium oxybate) oral solution, to include an indication to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients. The user fee review action target date is 10/27\. Xyrem is currently indicated for treating the conditions in adult patients. The submission was filed in response to a Pediatric Written Request from FDA, according to Jazz, and it is based on data from the global Phase 2/3 EXPRESS study that assessed the safety, efficacy and pharmacokinetics of Xyrem in pediatric patients (seven to 17 years of age).