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The tentative approval granted by the US Food & Drug Administration (USFDA) is for its supplemental abbreviated new drug application (sANDA) Bosutinib tablets of strength 400 mg, Alembic said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug product, Bosulif tablets, 400 mg, of PF Prism CV, it added.
Bosutinib is indicated for the treatment of adult patients with “chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy”.
It is also used for treatment of “adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy”, the company said.
Alembic said it had previously received final approval for its ANDA Bosutinib tablets, 100 mg and 500mg.
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