Xyrem UCB Pharma Ltd · Authorised · authorised 13 Oct 2005 · ATC N07XX04
Therapeutic indication (EMA)
Treatment of narcolepsy with cataplexy in adult patients.
Active substance
Oxybate
- US FDA 6
- EMA 1
- Health Canada 2
- Safety 5
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| XYREM | 0.5GM/ML | solution · oral | JAZZ PHARMS | Prescription | 17 Jul 2002 |
| XYWAV | 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | solution · oral | JAZZ | Prescription | 21 Jul 2020 |
| LUMRYZ | 4.5GM/PACKET; 6GM/PACKET; 7.5GM/PACKET; 9GM/PACKET | for suspension, extended release · oral | ALKERMES INC | Prescription | 1 May 2023 |
| SODIUM OXYBATE | 0.5GM/ML | solution · oral | AMNEAL | Prescription | 10 Sep 2025 |
| SODIUM OXYBATE | 0.5GM/ML | solution · oral | ASCENT PHARMS INC | Prescription | 5 Nov 2025 |
| SODIUM OXYBATE | 0.5GM/ML | solution · oral | HIKMA PHARMS | Discontinued | 17 Jan 2017 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
Safety signals and safety-related labeling changes
- US FDA 12 Aug 2021 XYWAV — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 12 Aug 2021 XYWAV — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 12 Aug 2021 XYWAV — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 12 Aug 2021 XYWAV — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 11 Feb 2021 XYREM — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.