FDA — authorised 6 August 2014
- Marketing authorisation holder: THE MEDICINES CO
- Status: approved
🇺🇸 Orbactiv in United States
FDA authorised Orbactiv on 6 August 2014
Marketing authorisations
FDA — authorised 20 January 2016
- Application: NDA206334
- Marketing authorisation holder: MELINTA THERAP
- Indication: Labeling
- Status: approved
FDA — authorised 23 July 2021
- Application: NDA214155
- Marketing authorisation holder: MELINTA THERAP
- Indication: Labeling
- Status: approved
Orbactiv in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Orbactiv approved in United States?
Yes. FDA authorised it on 6 August 2014; FDA authorised it on 20 January 2016; FDA authorised it on 23 July 2021.
Who is the marketing authorisation holder for Orbactiv in United States?
THE MEDICINES CO holds the US marketing authorisation.