FDA — authorised 21 January 2020
- Application: BLA761143
- Marketing authorisation holder: HORIZON THERAPEUTICS IRELAND
- Local brand name: TEPEZZA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 TEPEZZA in United States
FDA authorised TEPEZZA on 21 January 2020
Marketing authorisation
TEPEZZA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is TEPEZZA approved in United States?
Yes. FDA authorised it on 21 January 2020.
Who is the marketing authorisation holder for TEPEZZA in United States?
HORIZON THERAPEUTICS IRELAND holds the US marketing authorisation.