🇺🇸 Cometriq in United States

FDA authorised Cometriq on 29 November 2012

Marketing authorisations

FDA — authorised 29 November 2012

Application: NDA203756
Marketing authorisation holder: EXELIXIS
Local brand name: COMETRIQ
Indication: CAPSULE — ORAL
Status: approved

The FDA approved Cometriq, a product of Exelixis, for its approved indication. This approval was granted through a standard expedited pathway. Cometriq's marketing authorization was issued on October 9, 2025, with application number NDA203756.

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FDA — authorised 22 January 2021

Application: NDA208692
Marketing authorisation holder: EXELIXIS INC
Indication: Efficacy
Status: approved

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FDA

Application: ANDA213878
Marketing authorisation holder: MSN LABORATORIES PRIVATE LTD
Local brand name: CABOZANTINIB
Indication: TABLET
Status: approved

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FDA

Application: ANDA220121
Marketing authorisation holder: BIOCON PHARMA LIMITED
Local brand name: CABOZANTINIB
Indication: TABLET
Status: approved

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FDA

Application: NDA220258
Marketing authorisation holder: AZURITY
Local brand name: RESNIBEN
Indication: TABLET — ORAL
Status: approved

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Cometriq 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 Cometriq approved in United States?

Yes. FDA authorised it on 29 November 2012; FDA authorised it on 22 January 2021; FDA has authorised it.

Who is the marketing authorisation holder for Cometriq in United States?

EXELIXIS holds the US marketing authorisation.