FDA — authorised 20 December 2005
- Marketing authorisation holder: BAYER HLTHCARE
- Status: approved
🇺🇸 Nexavar in United States
FDA authorised Nexavar on 20 December 2005
Marketing authorisations
FDA — authorised 16 November 2007
- Application: NDA021923
- Marketing authorisation holder: BAYER HLTHCARE
- Indication: Efficacy
- Status: approved
FDA — authorised 12 November 2020
- Application: ANDA209567
- Marketing authorisation holder: TEVA PHARMS USA INC
- Status: approved
FDA — authorised 7 June 2022
- Application: ANDA216073
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 12 April 2023
- Application: ANDA217095
- Marketing authorisation holder: TORRENT
- Status: approved
FDA — authorised 5 March 2024
- Application: ANDA207012
- Marketing authorisation holder: MYLAN
- Indication: Labeling
- Status: approved
The FDA approved Nexavar for labeling indications in the United States. This approval was granted to MYLAN on 2024-03-05 under application number ANDA207012. The approval was not designated as an expedited pathway.
Nexavar 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 Nexavar approved in United States?
Yes. FDA authorised it on 20 December 2005; FDA authorised it on 16 November 2007; FDA authorised it on 12 November 2020.
Who is the marketing authorisation holder for Nexavar in United States?
BAYER HLTHCARE holds the US marketing authorisation.