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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
Trade Name: SCENESSE®
Date Designated: 07/17/2008
Orphan Designation: Treatment of erythropoietic porphyrias
Orphan Designation Status: Designated/Approved
Clinuvel Inc.
P. O. Box 94026
Menlo Park, California 94026
United States

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

Marketing approved:

1 Generic Name: afamelanotide
Trade Name: SCENESSE®
Marketing Approval Date: 10/08/2019
Approved Labeled Indication: SCENESSE® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
Exclusivity End Date: 10/08/2026 
Exclusivity Protected Indication* :  Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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