FDA — authorised 31 October 2017
- Application: NDA210259
- Marketing authorisation holder: ASTRAZENECA
- Status: supplemented
🇺🇸 Calquence in United States
FDA authorised Calquence on 31 October 2017
Marketing authorisations
FDA — authorised 3 August 2022
- Application: NDA216387
- Marketing authorisation holder: ASTRAZENECA
- Status: supplemented
FDA
- Status: approved
Calquence 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 Calquence approved in United States?
Yes. FDA authorised it on 31 October 2017; FDA authorised it on 3 August 2022; FDA has authorised it.
Who is the marketing authorisation holder for Calquence in United States?
ASTRAZENECA holds the US marketing authorisation.