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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Pegfilgrastim
Trade Name: Neulasta
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: Pegfilgrastim
Trade Name: Neulasta
Marketing Approval Date: 11/13/2015
Approved Labeled Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)
Exclusivity End Date: 11/13/2022 
Exclusivity Protected Indication* :  To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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