FDA — authorised 21 March 2008
- Application: BLA125118
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Indication: Labeling
- Status: approved
🇺🇸 Orencia in United States
FDA authorised Orencia on 21 March 2008
Marketing authorisation
Orencia 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 Orencia approved in United States?
Yes. FDA authorised it on 21 March 2008.
Who is the marketing authorisation holder for Orencia in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.