FDA — authorised 3 July 2014
- Application: NDA206256
- Marketing authorisation holder: ACROTECH BIOPHARMA
- Local brand name: BELEODAQ
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA authorised Belinostat Injection on 3 July 2014
Yes. FDA authorised it on 3 July 2014.
ACROTECH BIOPHARMA holds the US marketing authorisation.