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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ataluren
Date Designated: 12/10/2014
Orphan Designation: Treatment of mucopolysaccharidosis type I
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/15/2018
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, New Jersey 07080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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