Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market Acalabrutinib Capsules, used in the treatment of mantle cell lymphoma, in the American market.
The company has received tentative approval from the US Food & Drug Administration (USFDA) for Acalabrutinib Capsules (100 mg), the drug maker said in a statement.
The company's product is therapeutically equivalent to AstraZeneca UK's Calquence Capsules (100 mg), it added.
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 leukaemia (CLL) or small lymphocytic lymphoma (SLL).
According to IQVIA, Acalabrutinib Capsules (100 mg) have an estimated market size of USD 1.5 billion for twelve months ending September 2022.
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