FDA — authorised 20 May 2014
- Application: BLA125476
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: ENTYVIO
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Vedolizumab SC in United States
FDA authorised Vedolizumab SC on 20 May 2014
Marketing authorisations
FDA — authorised 27 September 2023
- Application: BLA761133
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: ENTYVIO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 2024
- Application: BLA761359
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: ENTYVIO
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
Frequently asked questions
Is Vedolizumab SC approved in United States?
Yes. FDA authorised it on 20 May 2014; FDA authorised it on 27 September 2023; FDA authorised it on 18 April 2024.
Who is the marketing authorisation holder for Vedolizumab SC in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.