FDA — authorised 27 September 2010
- Application: BLA125274
- Marketing authorisation holder: IPSEN BIOPHARM LTD
- Indication: Labeling
- Status: approved
🇺🇸 Nuceiva in United States
FDA authorised Nuceiva on 27 September 2010
Marketing authorisations
FDA — authorised 11 August 2023
- Application: BLA761127
- Marketing authorisation holder: REVANCE THERAPEUTICS, INC.
- Indication: Efficacy
- Status: approved
Nuceiva 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 Nuceiva approved in United States?
Yes. FDA authorised it on 27 September 2010; FDA authorised it on 11 August 2023.
Who is the marketing authorisation holder for Nuceiva in United States?
IPSEN BIOPHARM LTD holds the US marketing authorisation.