FDA — authorised 5 April 2016
- Application: BLA125544
- Marketing authorisation holder: CELLTRION INC
- Local brand name: INFLECTRA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Remicade in United States
FDA authorised Remicade on 5 April 2016
Marketing authorisations
FDA
- Status: approved
Remicade in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Remicade approved in United States?
Yes. FDA authorised it on 5 April 2016; FDA has authorised it.
Who is the marketing authorisation holder for Remicade in United States?
CELLTRION INC holds the US marketing authorisation.