Cell Therapeutics' NDA for Pixantrone accepted by the FDA

Aug 24 2009

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.

"The FDA's acceptance to file our pixantrone NDA represents a significant milestone for CTI and for patients with relapsed and refractory aggressive NHL. We look forward to working with the FDA and their final decision on our request for priority review," noted James Bianco, M.D., Chief Executive Officer of CTI.