FDA — authorised 13 July 2017
- Marketing authorisation holder: JANSSEN BIOTECH
- Status: approved
🇺🇸 Tremfya in United States
FDA authorised Tremfya on 13 July 2017
Marketing authorisations
FDA — authorised 13 July 2020
- Application: BLA761061
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Efficacy
- Status: approved
Tremfya 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 Tremfya approved in United States?
Yes. FDA authorised it on 13 July 2017; FDA authorised it on 13 July 2020.
Who is the marketing authorisation holder for Tremfya in United States?
JANSSEN BIOTECH holds the US marketing authorisation.