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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: 03/12/1996
Orphan Designation: Treatment of Peyronie's disease.
Orphan Designation Status: Designated/Approved
Auxilium Pharmaceuticals, Inc.
640 Lee Road
Chesterbrook, Pennsylvania 19087
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: 12/06/2013
Approved Labeled Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Exclusivity End Date: 12/06/2020 
Exclusivity Protected Indication* :  Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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