USFDA gives tentative approval to Alembic Pharma’s acalabrutinib capsules, 100 mg

The United States Food and Drug Administration (USFDA) has given tentative approval to Alembic Pharma’s Abbreviated New Drug Application (ANDA), acalabrutinib capsules, 100 mg, according to a statement from Alembic Pharma.

The statement said that the approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, calquence capsules, 100 mg, of 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), the statement added.