Alembic Pharmaceuticals Ltd on Monday said it has received tentative approval from the US Food and Drug Administration (USFDA) for its Bosutinib tablets, used in the treatment of certain types of cancer.
In a regulatory filing, the company said the tentative approval has been granted for its supplemental abbreviated new drug application (sANDA) for Bosutinib tablets of 400 mg strength.
Alembic Pharmaceuticals added that the approved ANDA is therapeutically equivalent to the reference listed drug Bosulif tablets, 400 mg, marketed by **Pfizer subsidiary PF Prism CV.
The development marks another step forward in Alembic’s expanding portfolio of generic oncology products in the US market.