CAMBRIDGE, Mass.--(BUSINESS WIRE)--Xanthus Pharmaceuticals, Inc., a privately-held oncology and autoimmune disease drug development company, today announced that its New Drug Application (NDA) for fludarabine phosphate oral tablets (oral fludarabine) was accepted for filing by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed B-cell chronic lymphocytic leukemia (CLL). Filing of the NDA indicates that the registration package is sufficiently complete to allow for a thorough review of the data supporting the safety profile and effectiveness of oral fludarabine. Earlier this month Xanthus announced that the FDA granted Orphan Drug Designation for oral fludarabine for B-cell CLL. Xanthus licensed the exclusive right to develop and commercialize oral fludarabine in the United States from Schering AG (now Bayer Schering Pharma AG) in October of 2006.
