FDA — authorised 23 November 2020
- Application: NDA210854
- Marketing authorisation holder: GENENTECH INC
- Indication: Efficacy
- Status: approved
🇺🇸 Xofluza in United States
FDA authorised Xofluza on 23 November 2020
Marketing authorisations
FDA — authorised 23 November 2020
- Application: NDA214410
- Marketing authorisation holder: GENENTECH INC
- Local brand name: XOFLUZA
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Xofluza in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Xofluza approved in United States?
Yes. FDA authorised it on 23 November 2020; FDA authorised it on 23 November 2020.
Who is the marketing authorisation holder for Xofluza in United States?
GENENTECH INC holds the US marketing authorisation.