FDA — authorised 26 February 2021
- Marketing authorisation holder: ORIGIN
- Status: approved
🇺🇸 Nulibry in United States
FDA authorised Nulibry on 26 February 2021
Marketing authorisations
FDA — authorised 26 February 2021
- Application: NDA214018
- Marketing authorisation holder: SENTYNL THERAPS INC
- Local brand name: NULIBRY
- Indication: POWDER — INTRAVENOUS
- Status: approved
Nulibry 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 Nulibry approved in United States?
Yes. FDA authorised it on 26 February 2021; FDA authorised it on 26 February 2021.
Who is the marketing authorisation holder for Nulibry in United States?
ORIGIN holds the US marketing authorisation.