Eagle Pharmaceuticals announced that the FDA has granted Orphan Drug designation to bendamustine HCl for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (NHL).
Bendamustine HCl is a ready-to-dilute, low-volume concentrate solution for injection that will be administered via infusion over 10 minutes after dilution. This allows for a shorter infusion time than the currently marketed bendamustine HCl product, Treanda.
Cephalon, a subsidiary of Teva Pharmaceuticals, currently markets Treanda (bendamustine HCl). Treanda is a lyophilized powder for IV infusion after reconstitution and dilution that is already approved for CLL and indolent B-cell NHL that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. Treanda is infused over 30 minutes for CLL and 60 minutes for NHL.
For more information visit EagleUS.com.