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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: afamelanotide
Date Designated: 12/11/2009
Orphan Designation: Treatment of solar urticaria
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Clinuvel, Inc.
30 Broad Street
Suites 1407 and 1408
New York, New York 10004
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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