FDA — authorised 26 August 2014
- Application: NDA202570
- Marketing authorisation holder: PF PRISM CV
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Xalkori in United States
FDA authorised Xalkori on 26 August 2014
Marketing authorisations
FDA — authorised 7 September 2023
- Application: NDA217581
- Marketing authorisation holder: PF PRISM CV
- Indication: Type 3 - New Dosage Form
- Status: approved
Xalkori 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 Xalkori approved in United States?
Yes. FDA authorised it on 26 August 2014; FDA authorised it on 7 September 2023.
Who is the marketing authorisation holder for Xalkori in United States?
PF PRISM CV holds the US marketing authorisation.