FDA — authorised 6 August 2014
- Application: NDA206334
- Marketing authorisation holder: MELINTA THERAP
- Local brand name: ORBACTIV
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA authorised Current Formulation of Oritavancin on 6 August 2014
Yes. FDA authorised it on 6 August 2014.
MELINTA THERAP holds the US marketing authorisation.