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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
Trade Name: Neupogen
Date Designated: 10/01/1990
Orphan Designation: Treatment of neutropenia associated with bone marrow transplants.
Orphan Designation Status: Designated/Approved
Amgen, Inc.
1840 Dehavilland Drive
Thousand Oaks, California 91320
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Filgrastim
Trade Name: Neupogen
Marketing Approval Date: 06/15/1994
Approved Labeled Indication: Reduce the duration of neutropenia and neutropenia sequelae in patients with non-myeloid malignancies undergoing ablative chemotherapy followed by BMT.
Exclusivity End Date: 06/15/2001 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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