FDA — authorised 23 December 2005
- Application: BLA125118
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: ORENCIA
- Indication: INJECTABLE — IV (INFUSION)
- Status: approved
FDA authorised ABA, open-label (OL) on 23 December 2005
Yes. FDA authorised it on 23 December 2005.
BRISTOL MYERS SQUIBB holds the US marketing authorisation.