Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) Bosutinib Tablets, 400 mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug Product (RLD), Bosulif Tablets, 400 mg, of PF Prism CV (PF Prism CV).

Bosutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic phase Ph+ Chronic Myelogenous Leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy, and adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

The company had previously received final approval for its ANDA Bosutinib Tablets, 100 mg and 500mg. Bosutinib Tablets, 400 mg, have an estimated market size of USD 251 million for 12 months ending September 2025, according to IQVIA.

Alembic has a cumulative total of 232 ANDA approvals from the FDA.