Mumbai, Jan. 12 -- The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bosulif Tablets, 400 mg, of PF Prism C.V. Bosutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic-phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), including newly diagnosed patients as well as those resistant or intolerant to prior therapy. It is also indicated for adult patients with accelerated- or blast-phase Ph+ CML who are resistant or intolerant to earlier treatment.

Alembic had earlier received final approvals for Bosutinib Tablets in 100 mg and 500 mg strengths. The 400 mg strength has an estimated market size of about $251 million for the 12 months ended Septemb...