FDA
- Status: approved
🇺🇸 Cometriq in United States
Cometriq (Cabometyx) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA213878
- Marketing authorisation holder: MSN LABORATORIES PRIVATE LTD
- Local brand name: CABOZANTINIB
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA220121
- Marketing authorisation holder: BIOCON PHARMA LIMITED
- Local brand name: CABOZANTINIB
- Indication: TABLET
- Status: approved
FDA
- Application: NDA220258
- Marketing authorisation holder: AZURITY
- Local brand name: RESNIBEN
- Indication: TABLET — ORAL
- Status: approved
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 has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Cometriq in United States?
Exelixis is the originator. The local marketing authorisation holder may differ — check the official source linked above.