FDA — authorised 10 October 1974
- Application: NDA017284
- Marketing authorisation holder: SHINE
- Local brand name: XENON XE 133
- Indication: GAS — INHALATION
- Status: approved
🇺🇸 XENON XE 133 in United States
FDA authorised XENON XE 133 on 10 October 1974 · 5 US adverse-event reports
Marketing authorisations
FDA — authorised 11 October 1974
- Application: NDA017283
- Marketing authorisation holder: LANTHEUS MEDCL
- Local brand name: XENON XE 133
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 March 1976
- Application: NDA017550
- Marketing authorisation holder: GEN ELECTRIC
- Local brand name: XENON XE 133
- Indication: GAS — INHALATION
- Status: approved
FDA — authorised 9 November 1976
- Application: NDA017256
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: XENON XE 133
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 November 1976
- Application: NDA017687
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: XENON XE 133
- Indication: GAS — INHALATION
- Status: approved
FDA — authorised 9 March 1982
- Application: NDA018327
- Marketing authorisation holder: CURIUM
- Local brand name: XENON XE 133
- Indication: GAS — INHALATION
- Status: approved
FDA
- Application: NDA017262
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: XENEISOL
- Indication: SOLUTION — INHALATION, INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5
Most-reported reactions
- Accidental Exposure — 1 report (20%)
- Death — 1 report (20%)
- Erythema — 1 report (20%)
- Nausea — 1 report (20%)
- Vomiting — 1 report (20%)
XENON XE 133 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is XENON XE 133 approved in United States?
Yes. FDA authorised it on 10 October 1974; FDA authorised it on 11 October 1974; FDA authorised it on 24 March 1976.
Who is the marketing authorisation holder for XENON XE 133 in United States?
SHINE holds the US marketing authorisation.