FDA — authorised 21 January 2020
- Marketing authorisation holder: HORIZON THERAPEUTICS IRELAND
- Status: approved
🇺🇸 Tepezza in United States
FDA authorised Tepezza on 21 January 2020
Marketing authorisations
FDA — authorised 21 January 2020
- Application: BLA761143
- Marketing authorisation holder: HORIZON THERAPEUTICS IRELAND
- Local brand name: TEPEZZA
- Indication: INJECTABLE — INJECTION
- Status: approved
Tepezza 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 Tepezza approved in United States?
Yes. FDA authorised it on 21 January 2020; 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.