Mylan's generic leukemia drug gets green light from FDA
PITTSBURGH The Food and Drug Administration has approved a generic chemotherapy drug made by Mylan.
The Pittsburgh-based drug maker said Monday that it had received approval for the injected drug fludarabine phosphate in the 25-mg-per-mL strength. The FDA determined the drug to be therapeutically equivalent to Teva Parenteral’s fludarabine phosphate.
The drug is used to treat B-cell chronic lymphocytic leukemia and had sales of around $15 million during the 12-month period ended in June, according to IMS Health.