Alembic Pharma gets tentative USFDA nod for Acalabrutinib Capsules by admin- Thursday, January 19th, 2023 04:16:59 PM
Alembic Pharmaceuticals announced that it has received tentative approval from america Food & Drug Administration (USFDA) for its
Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg. The authorized ANDA is therapeutically equal to the reference listed drug product (RLD), Calquence Capsules, a hundred mg, of AstraZeneca UK Limited (AstraZeneca).
Acalabrutinib Capsules are indicated for the remedy of grownup patients with mantle mobile lymphoma (MCL) who have obtained at least one previous therapy and remedy of adult sufferers with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Acalabrutinib Capsules, a hundred mg, have an predicted market length of US$1.5billion for 12 months ending Sep 2022 in step with IQVIA.