Alembic Pharmaceuticals Limited has announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product, Bosulif Tablets, 400 mg, of PF Prism C.V. Bosutinib is a kinase inhibitor used for treating adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML) and adult patients with accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy.

Alembic had previously received final approval for its ANDA Bosutinib Tablets in 100 mg and 500mg strengths. The estimated market size for Bosutinib Tablets, 400 mg, was US$ 251 million for the twelve months ending September 2025, according to IQVIA.

With this approval, Alembic Pharmaceuticals now has a cumulative total of 232 ANDA approvals from the USFDA, comprising 212 final approvals and 20 tentative approvals.