FDA — authorised 14 May 2021
- Application: NDA215014
- Marketing authorisation holder: APELLIS PHARMS
- Local brand name: EMPAVELI
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 APL-2 in United States
FDA authorised APL-2 on 14 May 2021
Marketing authorisation
Other Immunology approved in United States
Frequently asked questions
Is APL-2 approved in United States?
Yes. FDA authorised it on 14 May 2021.
Who is the marketing authorisation holder for APL-2 in United States?
APELLIS PHARMS holds the US marketing authorisation.