FDA — authorised 19 March 2019
- Application: NDA211371
- Marketing authorisation holder: SAGE THERAP
- Local brand name: ZULRESSO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 ZULRESSO® in United States
FDA authorised ZULRESSO® on 19 March 2019
Marketing authorisations
FDA
- Status: approved
ZULRESSO® 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 ZULRESSO® approved in United States?
Yes. FDA authorised it on 19 March 2019; FDA has authorised it.
Who is the marketing authorisation holder for ZULRESSO® in United States?
SAGE THERAP holds the US marketing authorisation.