FDA — authorised 5 April 2016
- Application: BLA125544
- Marketing authorisation holder: CELLTRION INC
- Local brand name: INFLECTRA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CT-P13 in United States
FDA authorised CT-P13 on 5 April 2016
Marketing authorisation
CT-P13 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology / Rheumatology approved in United States
Frequently asked questions
Is CT-P13 approved in United States?
Yes. FDA authorised it on 5 April 2016.
Who is the marketing authorisation holder for CT-P13 in United States?
CELLTRION INC holds the US marketing authorisation.