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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Alprostadil
Date Designated: 10/20/1993
Orphan Designation: Treatment of severe peripheral arterial occlusive disease (critical limb ischemia) in patients where other procedures, grafts or angioplasty, are not indicated.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Schwarz Pharma, Inc.
P.O. Box 2038
Milwaukee, Wisconsin 53201
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.