FDA — authorised 30 October 2019
- Application: BLA761094
- Marketing authorisation holder: DOMPE FARMACEUTICI
- Indication: Labeling
- Status: approved
🇺🇸 Oxervate in United States
FDA authorised Oxervate on 30 October 2019
Marketing authorisation
Oxervate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Oxervate approved in United States?
Yes. FDA authorised it on 30 October 2019.
Who is the marketing authorisation holder for Oxervate in United States?
DOMPE FARMACEUTICI holds the US marketing authorisation.