Back to Stakeholders
Categories

1 domain / 2 areas / 1 specialization

Government, Policy & Advocacy
Government, Policy & Advocacy
Regulation & EnforcementREMS Administrators

Jazz Pharmaceuticals plc

Data updated

Biopharmaceutical company that administers the U.S. XYWAV and XYREM REMS restricted distribution program, including certification, dispensing controls, and program reporting requirements.

Regulation & Enforcement Snapshot

REMS Administrators

Authority Type

REMS Program Administrator

Jurisdiction

National

Coverage

1 country

Binding Strength

Programmatic Requirement

Function Areas

Risk Evaluation and Mitigation OversightData Reporting RequirementsCompliance Monitoring and Inspections

Framework / Program

XYWAV and XYREM REMS Program

Policy Notes

Jazz operates a shared REMS program for XYWAV and XYREM with prescriber and pharmacy certification controls, restricted dispensing, and ongoing communication and monitoring obligations.

Verification

Verified

Psychedelic Engagement

Psychedelic-Adjacent Focus

Framework Status

Active

Last Verified

Apr 8, 2026

Primary Policy Link

Source Evidence

XYWAV and XYREM REMS Program

https://www.xywavxyremrems.com/

FDA Approval Letter - NDA 212690 (XYWAV) with REMS Requirements

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212690Orig1s000ltr.pdf

XYWAV Prescribing Information

https://www.xywavxyremrems.com/sites/default/files/2025-08/xywav.en.USPI.pdf

Quick Facts

Website
Visit