• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
 
Generic Name:  afamelanotide
Trade Name:  SCENESSE®
Date Designated:  07/17/2008
Orphan Designation:  Treatment of erythropoietic porphyrias
Orphan Designation Status:  Designated/Approved
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).
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-