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Auxilium (AUXL) Receives FDA Std. Review Status for XIAFLEX

December 27, 2012 7:01 AM EST Send to a Friend
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office biologic therapy for the potential treatment of Peyronie's disease (PD). Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to take action on the application by September 6, 2013.

XIAFLEX is currently approved in the U.S., EU, Canada and Switzerland for the treatment of adult Dupuytren's contracture patients with a palpable cord. XIAFLEX for the treatment of PD was granted orphan designation in the U.S. by the FDA in January 1996 and, if approved by the FDA, is expected to be the first and only biologic therapy indicated for the treatment of PD.




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