FDA — authorised 23 December 2016
- Marketing authorisation holder: BIOGEN
- Status: approved
🇺🇸 Spinraza in United States
FDA authorised Spinraza on 23 December 2016
Marketing authorisations
FDA — authorised 17 June 2019
- Application: NDA209531
- Marketing authorisation holder: BIOGEN IDEC
- Indication: Labeling
- Status: approved
Spinraza in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Spinraza approved in United States?
Yes. FDA authorised it on 23 December 2016; FDA authorised it on 17 June 2019.
Who is the marketing authorisation holder for Spinraza in United States?
BIOGEN holds the US marketing authorisation.