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Acalabrutinib fda approval date?

See the DrugPatentWatch profile for Acalabrutinib

What was the FDA approval date for acalabrutinib?

Acalabrutinib (Calquence) was first FDA-approved on November 21, 2017 for the treatment of mantle cell lymphoma. [1]

Was the approval for acalabrutinib expanded to other cancers later?

Yes. The FDA later granted additional approvals/expanded indications, including for chronic lymphocytic leukemia (CLL) and other related uses, but the original first-approval date remains November 21, 2017. [1]

Where can I verify the approval date?

You can confirm the approval date through the FDA’s drug label/approval information for Calquence, which lists the initial FDA approval date. [1]

Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210259



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