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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Recombinant methionyl human stem cell factor
Date Designated: 11/22/1995
Orphan Designation: Treatment of primary bone marrow failure.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Amgen, Inc.
One Amgen Center Drive
Thousand Oaks, California 91320
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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