.Auxilium Announces U.S. Food and Drug Administration Approval for XIAFLEX(TM) for the Treatment of Dupuytren's Contracture Auxilium to Host Conference Call and Webcast on Wednesday, February 3 at 8:30 a.m. Eastern Time (PressMethod) - Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL - News), a specialty biopharmaceutical company, today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for XIAFLEX� (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. The Company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March.
"We believe the approval of XIAFLEX represents a major breakthrough for patients suffering from the debilitating effects of Dupuytren's contracture," said Armando Anido, Chief Executive Officer and President of Auxilium. "XIAFLEX is the first and only FDA-approved nonsurgical treatment for Dupuytren's contracture. I want to thank the employees of Auxilium and all of the clinical investigators who worked so hard to make this breakthrough a reality."
The Company will market and sell XIAFLEX in the United States through a team of approximately 100 field sales managers and representatives, reimbursement specialists and managed market account directors. In addition, a staff of 11 highly trained medical science liaisons will provide medical support for XIAFLEX. The Company has established a distribution network that will allow health care providers to access XIAFLEX through specialty distributors and specialty pharmacies or in the institutional setting after they have undergone training on XIAFLEX and its administration. For information and questions on XIAFLEX, patients and physicians can contact Auxilium at 1-877-XIAFLEX.
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