Low-Volume, Short Infusion Time Tx Designated Orphan Drug for Hematological Cancers

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.

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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.