FDA — authorised 14 January 2011
- Application: NDA022454
- Marketing authorisation holder: GE HLTHCARE INC
- Local brand name: DATSCAN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Datscan in United States
FDA authorised Datscan on 14 January 2011
Marketing authorisations
FDA — authorised 30 March 2022
- Application: ANDA213792
- Marketing authorisation holder: CURIUM
- Status: approved
Datscan 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 Datscan approved in United States?
Yes. FDA authorised it on 14 January 2011; FDA authorised it on 30 March 2022.
Who is the marketing authorisation holder for Datscan in United States?
GE HLTHCARE INC holds the US marketing authorisation.