FDA — authorised 9 December 2010
- Application: BLA020772
- Marketing authorisation holder: QOL MEDCL
- Indication: REMS
- Status: approved
FDA authorised Sucraid on 9 December 2010
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 9 December 2010.
QOL MEDCL holds the US marketing authorisation.