🇺🇸 Spravato in United States

FDA authorised Spravato on 5 March 2019

Marketing authorisations

FDA — authorised 5 March 2019

  • Application: NDA211243
  • Marketing authorisation holder: JANSSEN PHARMS
  • Status: supplemented

FDA

  • 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 Neuroscience approved in United States

Frequently asked questions

Is Spravato approved in United States?

Yes. FDA authorised it on 5 March 2019; FDA has authorised it.

Who is the marketing authorisation holder for Spravato in United States?

JANSSEN PHARMS holds the US marketing authorisation.