FDA — authorised 7 March 2025
- Application: BLA761399
- Marketing authorisation holder: CELLTRION INC
- Local brand name: OMLYCLO
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Omalizumab Injection in United States
FDA authorised Omalizumab Injection on 7 March 2025
Marketing authorisation
Omalizumab Injection in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Omalizumab Injection approved in United States?
Yes. FDA authorised it on 7 March 2025.
Who is the marketing authorisation holder for Omalizumab Injection in United States?
CELLTRION INC holds the US marketing authorisation.