FDA — authorised 29 February 2024
- Application: BLA761225
- Marketing authorisation holder: HUGEL INC
- Local brand name: LETYBO
- Indication: POWDER, FOR SOLUTION
- Status: approved
🇺🇸 LETYBO in United States
FDA authorised LETYBO on 29 February 2024
Marketing authorisations
FDA
- Status: approved
LETYBO 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 LETYBO approved in United States?
Yes. FDA authorised it on 29 February 2024; FDA has authorised it.
Who is the marketing authorisation holder for LETYBO in United States?
HUGEL INC holds the US marketing authorisation.