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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: allantoin
Date Designated: 11/21/2002
Orphan Designation: Treatment of skin blistering and erosions associated with inherited epidermolysis bullosa
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/12/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Scioderm, Inc.
1007 Slater Road
Suite 170
Durham, North Carolina 27703
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.