FDA — authorised 15 May 2013
- Marketing authorisation holder: BAYER HLTHCARE
- Status: approved
🇺🇸 Xofigo in United States
FDA authorised Xofigo on 15 May 2013
Marketing authorisations
FDA — authorised 15 May 2013
- Application: NDA203971
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: XOFIGO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Xofigo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Xofigo approved in United States?
Yes. FDA authorised it on 15 May 2013; FDA authorised it on 15 May 2013.
Who is the marketing authorisation holder for Xofigo in United States?
BAYER HLTHCARE holds the US marketing authorisation.