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news.The US Food and Drug Administration (FDA) has granted final approval to Mylan for its abbreviated new drug application (ANDA) for Fludarabine Phosphate injection USP, 25mg/ml, packaged in 50mg/2ml Single-dose Vials.
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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.