FDA — authorised 3 December 2014
- Application: BLA125557
- Marketing authorisation holder: AMGEN
- Local brand name: BLINCYTO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Blincyto on 3 December 2014
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 3 December 2014.
AMGEN holds the US marketing authorisation.