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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: unoprostone isopropyl
Date Designated: 09/16/2010
Orphan Designation: Treatment of retinitis pigmentosa
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/02/2016
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
R-Tech Ueno, Ltd.
Kobe Hybrid Business Center, 3F
Chuo-ku
Kobe City, Hyogo
Japan

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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