Alembic Pharma gets USFDA nod to market generic cancer drug

Alembic Pharma gets USFDA nod to market generic cancer drug

Acalabrutinib Capsules have gained provisional approval from the US Food & Drug Administration, according to a statement from the pharmaceutical company.

FPJ Web DeskUpdated: Thursday, January 19, 2023, 03:12 PM IST
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Alembic Pharma gets USFDA nod to market generic cancer drug | Image: Alembic Pharma(Representative)

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, via a press release.

Acalabrutinib Capsules (100 mg) have gained provisional approval from the US Food & Drug Administration (USFDA), according to a statement from the pharmaceutical company.

According to the manufacturer, its product is therapeutically similar to Calquence Capsules (100 mg) by AstraZeneca UK.

Adult patients with mantle cell lymphoma (MCL) who have undergone at least one prior therapy as well as those with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma may benefit from acalabrutinib capsule therapy (SLL).

Acalabrutinib Capsules (100 mg) are expected to have a market worth USD 1.5 billion for the twelve months ending in September 2022, according to IQVIA.

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