FDA — authorised 22 August 2008
- Application: BLA125268
- Marketing authorisation holder: AMGEN
- Status: approved
FDA authorised Nplate on 22 August 2008
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 22 August 2008; FDA has authorised it.
AMGEN holds the US marketing authorisation.