Endo Pharmaceuticals Inc., a subsidiary of Endo International plc. today announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord. The updated label now includes a long-term, observational study demonstrating the rate of recurrence for up to 5 years after successful treatment with Xiaflex, and the efficacy and safety of retreatment in patients with recurrent DC.
DC is a chronic condition affecting the hand in which abnormal buildup of collagen can cause the fingers to bend and be drawn in toward the palm. It is a rare genetic condition affecting up to 7 percent of adults in the United States. An estimated 20 to 60 percent of cases may recur following treatment.
For more details, go to: http://www.endo.com/news-events/press-releases?c=123046&p=irol-newsArticle&ID=2048840