USFDA12 Jan 2026, 12:19 pm
Alembic Pharmaceuticals Receives USFDA Tentative Approval for Bosutinib Tablets, 400 mg
AI Summary
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 (sSANDA) for Bosutinib Tablets, 400 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 400 mg, of PF Prism C.V. Bosutinib is a kinase inhibitor indicated for the treatment of certain types of chronic myelogenous leukemia. The estimated market size for Bosutinib Tablets, 400 mg, is US$ 251 million for twelve months ending September 2025 according to IQVIA. Alembic has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA.
Key Highlights
- Alembic Pharmaceuticals receives USFDA tentative approval for Bosutinib Tablets, 400 mg
- The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 400 mg, of PF Prism C.V.
- Bosutinib is a kinase inhibitor indicated for the treatment of certain types of chronic myelogenous leukemia
- The estimated market size for Bosutinib Tablets, 400 mg, is US$ 251 million for twelve months ending September 2025 according to IQVIA
- Alembic has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA