• 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: 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)

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.