FDA — authorised 30 March 2022
- Application: ANDA213792
- Marketing authorisation holder: CURIUM
- Local brand name: IOFLUPANE I-123
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Ioflupane I 123 in United States
FDA authorised Ioflupane I 123 on 30 March 2022
Marketing authorisations
FDA — authorised 1 November 2022
- Application: NDA022454
- Marketing authorisation holder: GE HLTHCARE INC
- Indication: Efficacy
- Status: approved
FDA
- Marketing authorisation holder: CURIUM
- Status: approved
Ioflupane I 123 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Ioflupane I 123 approved in United States?
Yes. FDA authorised it on 30 March 2022; FDA authorised it on 1 November 2022; FDA has authorised it.
Who is the marketing authorisation holder for Ioflupane I 123 in United States?
CURIUM holds the US marketing authorisation.