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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: N-acetylcysteine and sodium thiosulfate
Date Designated: 08/31/2015
Orphan Designation: Prevention of platinum-induced toxicities in pediatric patients (0 through 16 years of age).
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Edward A. Neuwelt, MD
3181 SW Sam Jackson Park Road
Portland, Oregon 97239
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.