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Xiaflex Approval History

FDA Approved: Yes (First approved February 3, 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.

Development History and FDA Approval Process 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

Further information

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