FDA — authorised 24 April 2009
- Marketing authorisation holder: CENTOCOR ORTHO BIOTECH INC
- Status: approved
🇺🇸 Simponi in United States
FDA authorised Simponi on 24 April 2009
Marketing authorisations
FDA — authorised 24 April 2009
- Application: BLA125289
- Marketing authorisation holder: CENTOCOR ORTHO BIOTECH INC
- Local brand name: SIMPONI
- Indication: INJECTABLE — INJECTION
- Status: approved
Simponi 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 Simponi approved in United States?
Yes. FDA authorised it on 24 April 2009; FDA authorised it on 24 April 2009.
Who is the marketing authorisation holder for Simponi in United States?
CENTOCOR ORTHO BIOTECH INC holds the US marketing authorisation.