FDA — authorised 23 April 2019
- Marketing authorisation holder: AbbVie INC
- Status: approved
🇺🇸 Skyrizi in United States
FDA authorised Skyrizi on 23 April 2019
Marketing authorisations
FDA — authorised 16 June 2022
- Application: BLA761262
- Marketing authorisation holder: ABBVIE INC
- Local brand name: SKYRIZI
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
The FDA approved Skyrizi, a medication developed by AbbVie Inc., for its approved indication on January 3, 2024. The application number for this approval is BLA761262. Skyrizi was granted marketing authorization through the standard expedited pathway.
FDA — authorised 4 March 2024
- Application: BLA761105
- Marketing authorisation holder: ABBVIE INC
- Indication: Labeling
- Status: approved
The FDA approved Skyrizi, a medication developed by AbbVie Inc, for its approved indication on 4 March 2024. The application number for this approval is BLA761105. This approval was granted through the standard expedited pathway.
Skyrizi 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 Skyrizi approved in United States?
Yes. FDA authorised it on 23 April 2019; FDA authorised it on 16 June 2022; FDA authorised it on 4 March 2024.
Who is the marketing authorisation holder for Skyrizi in United States?
AbbVie INC holds the US marketing authorisation.