The US Food and Drug Administration (USFDA) has tentatively approved Alembic Pharmaceuticals’ Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg. The approved ANDA is therapeutically equivalent to AstraZeneca UK’s reference listed drug product (RLD), Calquence Capsules, 100 mg.
Acalabrutinib Capsules are approved for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy, as well as the treatment of adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). According to IQVIA, the market for Acalabrutinib Capsules, 100 mg, is worth US$1.5 billion in the twelve months ending September 2022. Alembic has received 180 ANDA approvals from the USFDA (157 final approvals and 23 tentative approvals).