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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: 11/07/1996
Orphan Designation: Reduction in the duration of neutropenia, fever, antibiotic use, and hospitalization, following induction and consolidation treatment for acute myeloid leukemia.
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: Filgrastim
Trade Name: Neupogen
Marketing Approval Date: 04/02/1998
Approved Labeled Indication: Reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia.
Exclusivity End Date: 04/02/2005 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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