FDA — authorised 5 December 2023
- Application: NDA218276
- Marketing authorisation holder: NOVARTIS
- Local brand name: FABHALTA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Fabhalta in United States
FDA authorised Fabhalta on 5 December 2023
Marketing authorisations
FDA
- Marketing authorisation holder: NOVARTIS
- Status: approved
Fabhalta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Fabhalta approved in United States?
Yes. FDA authorised it on 5 December 2023; FDA has authorised it.
Who is the marketing authorisation holder for Fabhalta in United States?
NOVARTIS holds the US marketing authorisation.