FDA — authorised 9 May 2023
- Marketing authorisation holder: CHIESI FARMACEUTICI S.P.A
- Status: approved
🇺🇸 Elfabrio in United States
FDA authorised Elfabrio on 9 May 2023
Marketing authorisations
FDA — authorised 9 May 2023
- Application: BLA761161
- Marketing authorisation holder: CHIESI FARMACEUTICI SPA
- Indication: Type 1 - New Molecular Entity
- Status: approved
Elfabrio in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Elfabrio approved in United States?
Yes. FDA authorised it on 9 May 2023; FDA authorised it on 9 May 2023.
Who is the marketing authorisation holder for Elfabrio in United States?
CHIESI FARMACEUTICI S.P.A holds the US marketing authorisation.