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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: dexrazoxane
Trade Name: Totect(r)
Date Designated: 03/25/2004
Orphan Designation: Treatment of anthracycline extravasation during chemotherapy
Orphan Designation Status: Designated/Approved
Clinigen, Inc.
790 Township Line Road
Suite 120
Yardley, Pennsylvania 19067
United States

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

Marketing approved:

1 Generic Name: dexrazoxane
Trade Name: Totect(r)
Marketing Approval Date: 09/06/2007
Approved Labeled Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy
Exclusivity End Date: 09/06/2014 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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