FDA — authorised 8 December 2008
- Application: NDA022244
- Marketing authorisation holder: EISAI INC
- Local brand name: LUSEDRA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA authorised Lusedra on 8 December 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 8 December 2008; FDA authorised it on 12 December 2008.
EISAI INC holds the US marketing authorisation.