Alembic Pharmaceuticals (NSE:APLLTD, BOM:533573) has received tentative approval from the US Food and Drug Administration (US FDA) for Bosutinib Tablets, 400 mg, according to a filing to the Indian stock exchanges.

The product is therapeutically equivalent to the PF Prism C.V.'s reference listed drug product Bosulif Tablets, 400 mg.

Bosutinib is a kinase inhibitor used to treat 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.

According to estimates by IQVIA, Bosutinib Tablets, 400 mg, have an estimated market size of $251 million for 12 months ending September 2025.

The company's shares were down nearly 1% in recent trade.