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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Epoetin alpha
Date Designated: 08/27/1987
Orphan Designation: Treatment of anemia associated with end stage renal disease.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
R. W. Johnson Pharmaceutical Research Institute
Route 202 South
P.O. Box 300
Raritan, New Jersey 08869
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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