Mylan claims that its Fludarabine Phosphate injection USP, 25mg/ml is bioequivalent and therapeutically equivalent to Teva Parenteral’s Fludarabine Phosphate injection USP, 25mg/ml.
Fludarabine is a chemotherapy drug that interferes with the growth of cancer cells. It is usually used to treat chronic lymphocytic leukemia (CLL).
Currently, Mylan has 150 ANDAs pending FDA approval.