Alembic Pharmaceuticals Limited announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets in 100 mg and 500 mg strengths.
The approved product is therapeutically equivalent to the reference listed drug (RLD), Bosulif Tablets (100 mg and 500 mg), marketed by PF Prism C.V. Bosutinib is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy. (Please refer to the label for full prescribing information.)
According to IQVIA data, the market size for Bosutinib Tablets (100 mg and 500 mg) in the U.S. was approximately USD 291 million for the 12-month period ending March 2025.
With this approval, Alembic now has a total of 223 ANDA approvals from the USFDA, comprising 200 final approvals and 23 tentative approvals.