FDA — authorised 16 June 2025
- Application: BLA761367
- Marketing authorisation holder: CSL BEHRING LLC
- Local brand name: ANDEMBRY
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 ANDEMBRY in United States
FDA authorised ANDEMBRY on 16 June 2025
Marketing authorisations
FDA
- Status: approved
ANDEMBRY 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 ANDEMBRY approved in United States?
Yes. FDA authorised it on 16 June 2025; FDA has authorised it.
Who is the marketing authorisation holder for ANDEMBRY in United States?
CSL BEHRING LLC holds the US marketing authorisation.