FDA — authorised 10 November 2015
- Marketing authorisation holder: GENENTECH INC
- Status: approved
🇺🇸 Cotellic in United States
FDA authorised Cotellic on 10 November 2015
Marketing authorisations
FDA — authorised 26 January 2018
- Application: NDA206192
- Marketing authorisation holder: GENENTECH INC
- Indication: Efficacy
- Status: approved
Cotellic 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 Cotellic approved in United States?
Yes. FDA authorised it on 10 November 2015; FDA authorised it on 26 January 2018.
Who is the marketing authorisation holder for Cotellic in United States?
GENENTECH INC holds the US marketing authorisation.