FDA — authorised 8 April 1996
- Application: NDA050704
- Marketing authorisation holder: GALEN (UK)
- Local brand name: DAUNOXOME
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- Status: approved
FDA authorised Liposomal daunorubicin on 8 April 1996
Yes. FDA authorised it on 8 April 1996.
GALEN (UK) holds the US marketing authorisation.