FDA — authorised 24 January 2025
- Application: BLA761420
- Marketing authorisation holder: CELLTRION INC
- Local brand name: AVTOZMA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 AVTOZMA in United States
FDA authorised AVTOZMA on 24 January 2025
Marketing authorisations
FDA — authorised 21 January 2026
- Application: BLA761498
- Marketing authorisation holder: CELLTRION INC
- Local brand name: AVTOZMA
- Indication: INJECTABLE — IV (INFUSION)
- Status: approved
FDA
- Status: approved
AVTOZMA 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 AVTOZMA approved in United States?
Yes. FDA authorised it on 24 January 2025; FDA authorised it on 21 January 2026; FDA has authorised it.
Who is the marketing authorisation holder for AVTOZMA in United States?
CELLTRION INC holds the US marketing authorisation.