Auxilium Pharma (AUXL) Said FDA Panel To Review XIAFLEX In September, Not August
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Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) announced that the FDA's Arthritis Advisory Committee will review XIAFLEX during an advisory committee hearing, tentatively scheduled to take place on September 16, 2009.
XIAFLEX (collagenase clostridium histolyticum) is a novel, first-in-class, orphan-designated, biologic for the treatment of Dupuytren's contracture. Auxilium filed its Biologics License Application (BLA) for XIAFLEX for the treatment of Dupuytren's contracture on February 27, 2009. The FDA has not updated the Prescription Drug User Fee Act (PDUFA) date of August 28, 2009.
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