Auxilium Pharma Receives FDA Notification Of XIAFLEX PDUFA Date Extension

(RTTNews) - Specialty biopharmaceutical company Auxilium Pharmaceuticals, Inc. (AUXL) Wednesday said it received a notification from the U.S. Food and Drug Administration, or FDA, regarding extension of the Prescription Drug User Fee Act or PDUFA goal date for its supplemental biologics license application for XIAFLEX, used for the treatment of Peyronie's disease. The PDUFA goal date has been extended to December 6 from previously announced September 6.

During the course of recent product label discussions, Auxilium said, it submitted revisions regarding its proposed Risk Evaluation and Mitigation Strategy program and other aspects related to the proposed label. The FDA determined that this submission qualified as a major amendment filed during the final three months of the review and extended the PDUFA goal date. Auxilium said that the FDA did not request for any additional clinical studies be performed before the revised date.

"We are continuing to prepare for commercialization in Peyronie's disease, assuming FDA approval by the revised PDUFA date." said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals.