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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: difluprednate
Trade Name: Durezol
Date Designated: 09/30/2008
Orphan Designation: Treatment of endogenous and traumatic anterior uveitis and panuveitis.
Orphan Designation Status: Designated/Approved
Alcon Pharmaceuticals. Ltd.
Route Des Arsenaux 41
(P.O. Box 61)
Fribourg
Switzerland

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

Marketing approved:

1 Generic Name: difluprednate
Trade Name: Durezol
Marketing Approval Date: 06/13/2012
Approved Labeled Indication: Treatment of endogenous anterior uveitis
Exclusivity End Date: 06/13/2019 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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