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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 sodium
Trade Name: Photofrin
Date Designated: 06/06/1989
Orphan Designation: For the photodynamic therapy of patients with primary or recurrent obstructing (either partially or completely) esophageal carcinoma.
Orphan Designation Status: Designated/Approved
QLT Phototherapeutics, Inc.
Lederle Laboratories
401 North Middletown Road
Pearl River, New York 10965
United States

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

Marketing approved:

1 Generic Name: Porfimer sodium
Trade Name: Photofrin
Marketing Approval Date: 12/27/1995
Approved Labeled Indication: Photodynamic therapy with PHOTOFRIN for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who cannot be satisfactorily treated with Nd:YAG laser therapy.
Exclusivity End Date: 12/27/2002 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.