• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
Generic Name: filgrastim
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
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.

Marketing approved:

1 Generic Name: filgrastim
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).

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-