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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: porfimer
Trade Name: Photofrin
Date Designated: 10/19/2001
Orphan Designation: For the ablation of High-Grade Dysplasia in Barrett's Esophagus in patients who are not considered to be candidates for esophagectomy
Orphan Designation Status: Designated/Approved
Axcan Scandipharm Inc.
22 Inverness Parkway
Suite 310
Birmingham, Alabama 35242
United States

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

Marketing approved:

1 Generic Name: porfimer
Trade Name: Photofrin
Marketing Approval Date: 08/01/2003
Approved Labeled Indication: For the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy
Exclusivity End Date: 08/01/2010 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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