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News Breaks
June 25, 2014
08:09 EDTAUXLAuxilium files for EU approval of Xiapex for Peyronies disease
Auxilium and Swedish Orphan Biovitrum AB announced that Sobi has filed for an extension of the label for Xiapex - collagenase clostridium histolyticum - with the EMA to include the indication of Peyronie's disease. The filing is based on positive safety and efficacy outcome data from two double-blind placebo-controlled studies. Sobi is Marketing Authorisation Holder for Xiapex in 28 EU member countries as well as Norway and Iceland.
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