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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  dexamethasone intravitreal implant
Trade Name:  Ozurdex
Date Designated:  09/11/1998
Orphan Designation:  Treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate, posterior, and panuveitis
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/24/2010 
Approved Labeled Indication:  For treatment of non-infectious uveitis affecting the posterior segment of the eye
Exclusivity End Date:    09/24/2017 
Exclusivity Protected Indication* :  
2525 Dupont Drive
Irvine, California 92623
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.