FDA — authorised 28 September 2023
- Application: BLA761204
- Marketing authorisation holder: AMICUS THERAP US
- Local brand name: POMBILITI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 POMBILITI in United States
FDA authorised POMBILITI on 28 September 2023
Marketing authorisations
FDA
- Status: approved
POMBILITI in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is POMBILITI approved in United States?
Yes. FDA authorised it on 28 September 2023; FDA has authorised it.
Who is the marketing authorisation holder for POMBILITI in United States?
AMICUS THERAP US holds the US marketing authorisation.