FDA — authorised 17 August 2011
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Status: approved
🇺🇸 Zelboraf in United States
FDA authorised Zelboraf on 17 August 2011
Marketing authorisations
FDA — authorised 3 July 2013
- Application: NDA202429
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Indication: Labeling
- Status: approved
Zelboraf 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 Zelboraf approved in United States?
Yes. FDA authorised it on 17 August 2011; FDA authorised it on 3 July 2013.
Who is the marketing authorisation holder for Zelboraf in United States?
HOFFMANN LA ROCHE holds the US marketing authorisation.