FDA — authorised 26 January 2018
- Marketing authorisation holder: AAA USA INC
- Status: approved
🇺🇸 Lutathera in United States
FDA authorised Lutathera on 26 January 2018
Marketing authorisations
FDA — authorised 26 January 2018
- Application: NDA208700
- Marketing authorisation holder: AAA USA INC
- Local brand name: LUTATHERA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Lutathera in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Lutathera approved in United States?
Yes. FDA authorised it on 26 January 2018; FDA authorised it on 26 January 2018.
Who is the marketing authorisation holder for Lutathera in United States?
AAA USA INC holds the US marketing authorisation.