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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Titanium dioxide and bisoctrizole
Date Designated: 05/25/2005
Orphan Designation: For the secondary prevention (prevention of lesional induction) of disorders with UV-A and visible light-induced photosensitivity, specifically Actinic prurigo, Hydroa vacciniforme, Solar urticara (SU), Chronic Actinic Dermatitis (CAD), the cutaneous prophyrias, Smith-Lemli-Optiz Syndrome, and Hartnup's Disease.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Orfagen
CRDPF - LANGLADE
Toulouse, Cedex
France

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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