Auxilium's Xiaflex delayed

FDA extended by three months the PDUFA date for an sBLA from Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) to expand the label for Xiaflex collagenase clostridium to treat Peyronie's disease. The new date is Dec. 6; it was Sept. 6. According to Auxilium, the delay was due to the company's submission of revisions to its proposed REMS and label. Auxilium already markets Xiaflex in the U.S., Canada and the EU, where it is known as Xiapex, to treat Dupuytren's contracture in adult patients with a palpable cord, which affects joints in the hand. ...