Search Orphan Drug Designations and Approvals
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Generic Name: | Filgrastim | ||||||||||||||||
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Trade Name: | Neupogen | ||||||||||||||||
Date Designated: | 07/17/1995 | ||||||||||||||||
Orphan Designation: | For use in the mobilization of peripheral blood progenitor cells for collection in patients who will receive myeloablative or myelosuppressive chemotherapy. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Amgen, Inc. 1840 Dehavilland Drive Thousand Oaks, California 91320 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Filgrastim |
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Trade Name: | Neupogen | |
Marketing Approval Date: | 12/28/1995 | |
Approved Labeled Indication: | For use in the mobilization of hematopoietic progenitor cells into the peripheral blood collection by leukapheresis. | |
Exclusivity End Date: | 12/28/2002 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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