FDA — authorised 17 February 2006
- Application: NDA021632
- Marketing authorisation holder: VICURON HOLDINGS
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA authorised Eraxis on 17 February 2006
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 17 February 2006.
VICURON HOLDINGS holds the US marketing authorisation.