FDA — authorised 25 April 2023
- Marketing authorisation holder: BIOGEN MA
- Status: approved
🇺🇸 Qalsody in United States
FDA authorised Qalsody on 25 April 2023
Marketing authorisations
FDA — authorised 25 April 2023
- Application: NDA215887
- Marketing authorisation holder: BIOGEN MA
- Local brand name: QALSODY
- Indication: SOLUTION — INTRATHECAL
- Status: approved
Qalsody in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Qalsody approved in United States?
Yes. FDA authorised it on 25 April 2023; FDA authorised it on 25 April 2023.
Who is the marketing authorisation holder for Qalsody in United States?
BIOGEN MA holds the US marketing authorisation.