FDA — authorised 24 October 2018
- Application: NDA210854
- Marketing authorisation holder: GENENTECH INC
- Local brand name: XOFLUZA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Xofluza in United States
FDA authorised Xofluza on 24 October 2018
Marketing authorisations
FDA — authorised 23 November 2020
- Application: NDA214410
- Marketing authorisation holder: GENENTECH INC
- Local brand name: XOFLUZA
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Marketing authorisation holder: GENENTECH INC
- 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 24 October 2018; FDA authorised it on 23 November 2020; FDA has authorised it.
Who is the marketing authorisation holder for Xofluza in United States?
GENENTECH INC holds the US marketing authorisation.