Alembic Pharma Gets USFDA Nod For Generic Bosutinib Tablets

Alembic Pharmaceuticals on Friday said it has received final approval from the US Food and Drug Administration for its abbreviated new drug application for Bosutinib tablets in 100 mg and 500 mg strengths.

The tablets are a generic version of PF Prism C.V.'s Bosulif and are used to treat adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myelogenous leukaemia who are resistant or intolerant to prior therapy.

Citing IQVIA data, Alembic said the drug had an estimated market size of $291 million for the year ended March.