FDA — authorised 3 May 2019
- Marketing authorisation holder: JANSSEN PHARMS
- Status: approved
🇺🇸 Spravato in United States
FDA authorised Spravato on 3 May 2019
Marketing authorisations
FDA — authorised 18 October 2023
- Application: NDA211243
- Marketing authorisation holder: JANSSEN PHARMS
- Indication: Labeling
- Status: approved
Spravato 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 Spravato approved in United States?
Yes. FDA authorised it on 3 May 2019; FDA authorised it on 18 October 2023.
Who is the marketing authorisation holder for Spravato in United States?
JANSSEN PHARMS holds the US marketing authorisation.