FDA — authorised 29 September 2023
- Application: BLA761354
- Marketing authorisation holder: BIOGEN MA
- Local brand name: TOFIDENCE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 TOFIDENCE in United States
FDA authorised TOFIDENCE on 29 September 2023
Marketing authorisations
FDA
- Status: approved
TOFIDENCE 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 TOFIDENCE approved in United States?
Yes. FDA authorised it on 29 September 2023; FDA has authorised it.
Who is the marketing authorisation holder for TOFIDENCE in United States?
BIOGEN MA holds the US marketing authorisation.