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. This development further strengthens Alembic’s oncology portfolio in the highly regulated US generics market.
The approved sANDA is therapeutically equivalent to the reference listed drug Bosulif Tablets, 400 mg, marketed by PF Prism C.V.. Bosutinib is a kinase inhibitor indicated for the treatment of adult patients with Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML). The therapy is used in newly diagnosed patients as well as in those who are resistant or intolerant to prior treatment. It is also indicated for adult patients with accelerated or blast phase Ph+ CML who have shown resistance or intolerance to earlier therapies.
Alembic had earlier received final USFDA approvals for Bosutinib Tablets in the 100 mg and 500 mg strengths. With the tentative approval for the 400 mg dosage, the company continues to expand the dosage coverage of this critical oncology medication, enhancing its competitive positioning in the US market.
According to data from IQVIA, Bosutinib Tablets, 400 mg, have an estimated market size of approximately US$ 251 million for the twelve months ended September 2025, highlighting the commercial significance of this approval once it converts into final clearance.
With this latest milestone, Alembic Pharmaceuticals now has a cumulative total of 232 ANDA approvals from the USFDA, comprising 212 final approvals and 20 tentative approvals.