Alembic Pharmaceuticals Limited on Thursday 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.
Acalabrutinib is a type of chemotherapy and antineoplastic (anti-cancer) drug that belongs to a class called tyrosine kinase inhibitors (TKI).
It is a medication used to treat various types of non-Hodgkin lymphoma, including mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic leukemia.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited (AstraZeneca).
Acalabrutinib Capsules, 100 mg, have an estimated market size of $ 1.5 billion 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 the USFDA.
