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News Breaks
December 20, 2013
06:37 EDTAUXLAuxilium submits approval application to FDA for Xiaflex
Auxilium Pharmaceuticals announced the submission of a supplemental Biologics License Application, or sBLA, to the FDA requesting approval of Xiaflex for the treatment of multiple Dupuytren's contracture, or DC, cords concurrently. It is estimated that 35%-40%of annual surgical procedures in the U.S. are performed to treat more than one DC cord at a time. Xiaflex is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiaflex has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.
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April 14, 2014
08:16 EDTAUXLAuxilium management to meet with UBS
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April 11, 2014
07:06 EDTAUXLVIVUS announces avanafil clinical data presentation
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