FDA — authorised 18 November 2011
- Marketing authorisation holder: JAZZ PHARMS INC
- Status: approved
FDA authorised Erwinase on 18 November 2011
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 18 November 2011.
JAZZ PHARMS INC holds the US marketing authorisation.