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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Iloprost solution for infusion
Date Designated: 09/21/1989
Orphan Designation: Treatment of Raynaud's phenomenon secondary to systemic sclerosis.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Berlex Laboratories, Inc.
300 Fairfield Road
Wayne, New Jersey 07470
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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