🇺🇸 Cabozantinib monotherapy in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Cabozantinib monotherapy on 25 April 2016

Marketing authorisation

FDA — authorised 25 April 2016

Application: NDA208692
Marketing authorisation holder: EXELIXIS INC
Local brand name: CABOMETYX
Indication: TABLET — ORAL
Status: approved

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Frequently asked questions

Is Cabozantinib monotherapy approved in United States?

Yes. FDA authorised it on 25 April 2016.

Who is the marketing authorisation holder for Cabozantinib monotherapy in United States?

EXELIXIS INC holds the US marketing authorisation.