Search Orphan Drug Designations and Approvals
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Generic Name: | sodium thiosulfate | ||||||||||||||||
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Trade Name: | Pedmark | ||||||||||||||||
Date Designated: | 03/17/2004 | ||||||||||||||||
Orphan Designation: | Prevention of platinum-induced ototoxicity in pediatric patients | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | sodium thiosulfate |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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