Alembic Pharma Secures USFDA Tentative Approval for Bosulif Generic Bosutinib 400 mg
Written By : sheeba farhat
Published On 2026-01-12 18:00 GMT | Update On 2026-01-12 18:00 GMT
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New Delhi: Alembic Pharmaceuticals Limited (Alembic) has announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) 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. (PF Prism C.V.). Bosutinib is a kinase inhibitor indicated for the treatment of
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