The FDA has approved XiafleX™ (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord. The Agency has requested the company implement a risk evaluation and mitigation strategy (REMS) programme to evaluate and mitigate known and potential risks and serious adverse events; to inform healthcare providers about how to properly inject the drug and perform finger extension procedures; and, to inform patients about the serious risks associated with treatment.