Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosutinib Tablets, 100 mg and 500 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V. (PF Prism).
Bosutinib tablets are indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
Bosutinib Tablets, 100 mg and 500 mg have an estimated market size of $291 million for twelve months ending March 2025 according to IQVIA. The company has a cumulative total of 223 ANDA approvals (200 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals is principally engaged in the manufacturing and selling of pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.
