FDA authorised Calquence on 5 June 2024
The FDA approved Calquence (acalabrutinib), a kinase inhibitor, for its approved indication. The approval was granted to AstraZeneca, the marketing authorization holder. The application number for this approval is NDA216387.
The FDA approved Calquence (acalabrutinib), a kinase inhibitor, for its approved indication. The approval was granted to AstraZeneca, the marketing authorization holder. The application number for this approval is NDA210259.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 5 June 2024; FDA authorised it on 5 June 2024; FDA has authorised it.
ASTRAZENECA holds the US marketing authorisation.