Alembic Pharma's Leukemia Treatment Receives Tentative USFDA Nod

Alembic Pharmaceuticals Limited announced on Monday that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets in 100 mg and 500 mg strengths. The company stated that the approved ANDA is therapeutically equivalent to Bosulif Tablets (100 mg and 500 mg) by PF Prism C.V. Bosutinib tablets are indicated for treating Philadelphia chromosome-positive chronic myelogenous leukemia. According to IQVIA, the market size for Bosutinib Tablets is estimated at US$ 275 million for the twelve months ending March 2024. Alembic now holds a cumulative total of 206 ANDA approvals from the USFDA, comprising 179 final approvals and 27 tentative approvals.