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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
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* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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