FDA — authorised 31 March 2020
- Application: BLA125476
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Labeling
- Status: approved
🇺🇸 Entyvio in United States
FDA authorised Entyvio on 31 March 2020
Marketing authorisations
FDA — authorised 23 February 2024
- Application: BLA761133
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Labeling
- Status: approved
Takeda Pharmaceuticals USA received marketing authorization from the FDA for Entyvio on February 23, 2024. The approval was granted under the standard expedited pathway. Entyvio is a medication used for its approved indication, as stated in the labeling.
Entyvio in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Entyvio approved in United States?
Yes. FDA authorised it on 31 March 2020; FDA authorised it on 23 February 2024.
Who is the marketing authorisation holder for Entyvio in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.