Xiaflex Approval History beta

  • FDA approved: Yes (First approved February 3rd, 2010)
  • Brand name: Xiaflex
  • Generic name: collagenase clostridium histolyticum
  • Company: BioSpecifics Technologies Corp.
  • Treatment for: Dupuytren's Contracture

Xiaflex (collagenase clostridium histolyticum) is a collagenase product for the treatment of Dupuytren's contracture, a condition that affects the connective tissue that lies beneath the skin in the palm.

FDA Approval History for Xiaflex

DateArticle
Dec  6, 2013Approval FDA Approves Xiaflex as First Drug Treatment for Peyronie’s Disease
Feb  3, 2010Approval Auxilium Announces U.S. Food and Drug Administration Approval for Xiaflex for the Treatment of Dupuytren's Contracture
Sep 17, 2009FDA Advisory Committee Unanimously Recommends Approval of Xiaflex for Treatment of Dupuytren's Disease
Apr 29, 2009BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for Xiaflex for the Treatment of Dupuytren's Disease

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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