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Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited (AstraZeneca). Acalabrutinib Capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Acalabrutinib Capsules, 100 mg, have an estimated market size of US$1.5billion for twelve months ending Sep 2022 according to IQVIA.
Alembic has a cumulative total of 180 ANDA approvals (157 final approvals and 23 tentative approvals) from USFDA.