FDA — authorised 29 August 2017
- Marketing authorisation holder: REMPEX PHARMS INC
- Status: approved
🇺🇸 Vabomere in United States
FDA authorised Vabomere on 29 August 2017
Marketing authorisations
FDA — authorised 6 July 2018
- Application: NDA209776
- Marketing authorisation holder: REMPEX
- Indication: Labeling
- Status: approved
Vabomere in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Vabomere approved in United States?
Yes. FDA authorised it on 29 August 2017; FDA authorised it on 6 July 2018.
Who is the marketing authorisation holder for Vabomere in United States?
REMPEX PHARMS INC holds the US marketing authorisation.