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# Jazz Pharma Petitions FDA on Generic Xyrem Concerns
- URL: https://www.fdaweb.com/jazz-pharma-petitions-fda-on-generic-xyrem-concerns/
- Published: 2016-09-09T12:00:00.000Z
- Updated: 2026-09-14T21:30:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136758

A Jazz Pharmaceuticals [citizen petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-2672-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) asks FDA not to approve any generic applications that reference its Xyrem (sodium oxybate) oral solution if they carve out labeling about a drug interaction with divalproex sodium. The petition also asks the agency not to approve any generic Xyrem that does not include the portions of the Xyrem risk evaluation and mitigation strategy related to divalproex. Xyrem is indicated for treating cataplexy and excessive daytime sleepiness in narcolepsy.

Jazz says that recent public court filings indicate that at least one ANDA filer may be trying to “carve out” information regarding divalproex from its product’s package insert. “Omitting that information would render the generic less safe or effective than Xyrem and, therefore, unapprovable under 21 CFR § 314.127(a)(7),” it says. The company notes that the Xyrem REMS program also requires specific risk mitigation actions regarding the drug interaction, including prescriber education about the interaction and appropriate dose adjustments, as well as screening of all Xyrem patients for concomitant use with divalproex. A generic sodium oxybate REMS that does not require these risk mitigation efforts would not be approvable under FDA’s regulations, it says.