🇺🇸 Dayvigo in United States

FDA authorised Dayvigo on 20 December 2019

Marketing authorisations

FDA — authorised 20 December 2019

  • Marketing authorisation holder: EISAI INC
  • Status: approved

FDA — authorised 11 March 2022

  • Application: NDA212028
  • Marketing authorisation holder: EISAI INC
  • Indication: Labeling
  • Status: approved

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Dayvigo 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 Dayvigo approved in United States?

Yes. FDA authorised it on 20 December 2019; FDA authorised it on 11 March 2022.

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

EISAI INC holds the US marketing authorisation.