FDA — authorised 20 June 2003
- Application: BLA103976
- Marketing authorisation holder: GENENTECH
- Local brand name: XOLAIR
- Indication: SYRINGE
- Status: approved
🇺🇸 Xolair in United States
FDA authorised Xolair on 20 June 2003
Marketing authorisation
Xolair in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Xolair approved in United States?
Yes. FDA authorised it on 20 June 2003.
Who is the marketing authorisation holder for Xolair in United States?
GENENTECH holds the US marketing authorisation.