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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sodium thiosulfate
Trade Name: Pedmark
Date Designated: 03/17/2004
Orphan Designation: Prevention of platinum-induced ototoxicity in pediatric patients
Orphan Designation Status: Designated/Approved
Fennec Pharmaceuticals, Inc.
PO Box 13628
68 T.W. Alexander Drive
Research Triangle Park, North Carolina 27709
United States

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

Marketing approved:

1 Generic Name: sodium thiosulfate
Trade Name: Pedmark
Marketing Approval Date: 09/20/2022
Approved Labeled Indication: To reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors
Exclusivity End Date: 09/20/2029 
Exclusivity Protected Indication* :  To reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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