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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: collagenase clostridium histolyticum
Trade Name: Xiaflex
Date Designated: 05/23/1996
Orphan Designation: Treatment of advanced (involutional or residual stage) Dupuytren's disease
Orphan Designation Status: Designated/Approved
Auxilium Pharmaceuticals, Inc.
40 Valley Stream Parkway
Malvern, Pennsylvania 19335
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: collagenase clostridium histolyticum
Trade Name: Xiaflex
Marketing Approval Date: 02/02/2010
Approved Labeled Indication: Treatment of adult patients with Dupuytren's contracture with a palpable cord
Exclusivity End Date: 02/02/2017 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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