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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Filgrastim
Date Designated: 09/03/1991
Orphan Designation: Treatment of patients with AIDS who, in addition, are afflicted with cytomegalovirus retinitis and are being treated with ganciclovir
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Amgen, Inc.
One Amgen Center Dr.
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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