FDA — authorised 19 March 2014
- Application: NDA204677
- Marketing authorisation holder: LANTHEUS
- Local brand name: NEURACEQ
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 [18F]Florbetaben in United States
FDA authorised [18F]Florbetaben on 19 March 2014
Marketing authorisation
[18F]Florbetaben in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neurology approved in United States
Frequently asked questions
Is [18F]Florbetaben approved in United States?
Yes. FDA authorised it on 19 March 2014.
Who is the marketing authorisation holder for [18F]Florbetaben in United States?
LANTHEUS holds the US marketing authorisation.