FDA — authorised 21 December 2018
- Marketing authorisation holder: ALEXION PHARM
- Status: approved
🇺🇸 Ultomiris in United States
FDA authorised Ultomiris on 21 December 2018
Marketing authorisation
Ultomiris in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Ultomiris approved in United States?
Yes. FDA authorised it on 21 December 2018.
Who is the marketing authorisation holder for Ultomiris in United States?
ALEXION PHARM holds the US marketing authorisation.