Alembic receives tentative nod from USFDA for Acalabrutinib capsules

Alembic Pharmaceuticals Limited, an R&D pharmaceutical firm, 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, used for treating adult patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The approved capsules are therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited (AstraZeneca). Acalabrutinib capsules are usually used for treating adult patients with mantle cell lymphoma (MCL), who have received at least one prior therapy. It is also used for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). According to IQVIA data, Acalabrutinib capsules had an estimated market size of US$ 1.5 billion for twelve months ending in September 2022.