Search Orphan Drug Designations and Approvals
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Generic Name: | filgrastim | ||||||||||||||||
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Trade Name: | Neupogen | ||||||||||||||||
Date Designated: | 11/20/2013 | ||||||||||||||||
Orphan Designation: | Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Amgen, Inc. One Amgen Center Drive M/S 17-1-C 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: | 03/30/2015 | |
Approved Labeled Indication: | To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). | |
Exclusivity End Date: | 03/30/2022 | |
Exclusivity Protected Indication* : | To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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