Delcath Receives PDUFA Extension to September 13, 2013

Delcath Systems

today announced that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) goal date for its review of the Company's  New Drug Application (NDA) for the marketing approval of MelblezTM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), the Company's proprietary drug/device combination product for the treatment of patients with unresectable ocular melanoma metastatic to the liver. On March 18, 2013 the Company supplied certain information in response to an FDA request. The information related to clarification regarding the bridging studies that were performed between the filter generations that were used throughout the development program.  As the information was requested and supplied within 90 days of the June 15, 2013 PDUFA goal date, the agency exercised its option to extend the PDUFA goal date to provide adequate time for completion of its review. The three-month extension to September 13, 2013 is the standard extension cycle granted.   The previously announced Oncologic Drugs Advisory