Bendamustine RTD regulatory update
Eagle said FDA granted Orphan Drug designation to EP-3102 to treat chronic lymphocytic leukemia (CLL) and indolent B cell non-Hodgkin’s lymphoma (NHL). EP-3102 is a ready-to-dilute (RTD) formulation of bendamustine to be administered by infusion over 10 minutes after dilution in 50 mL saline or a mixture of sodium chloride and dextrose. Eagle plans to submit an NDA to FDA by year end for the product.
Earlier this month, Eagle received tentative approval for EP-3101 - an RTD formulation of bendamustine to be administered over 30 minutes for CLL and 60 minutes for NHL after dilution in 500 mL saline or a mixture of sodium chloride and dextrose - to treat indolent B cell NHL. The Cephalon Inc. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA, Petah Tikva, Israel) markets bendamustine in the U.S. as Treanda for CLL and indolent B cell NHL. ...