FDA — authorised 4 August 2023
- Marketing authorisation holder: SAGE THERAP
- Status: approved
🇺🇸 Zurzuvae in United States
FDA authorised Zurzuvae on 4 August 2023
Marketing authorisations
FDA — authorised 4 August 2023
- Application: NDA217369
- Marketing authorisation holder: BIOGEN INC
- Local brand name: ZURZUVAE
- Indication: CAPSULE — ORAL
- Status: approved
Zurzuvae 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 Zurzuvae approved in United States?
Yes. FDA authorised it on 4 August 2023; FDA authorised it on 4 August 2023.
Who is the marketing authorisation holder for Zurzuvae in United States?
SAGE THERAP holds the US marketing authorisation.