Auxilium announces FDA accepts Xiaflex sBLA

theflyonthewall.com

Auxilium announced that the FDA has accepted for filing and granted standard review status to its supplemental Biologics License Application for XIAFLEX, a novel, in-office biologic therapy for the potential treatment of Peyronie's disease. Under the Prescription Drug User Fee Act, the FDA is expected to take action on the application by September 6, 2013.

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