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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: romiplostim
Trade Name: Nplate
Date Designated: 05/24/2018
Orphan Designation: Treatment of patients acutely exposed to myelosuppressive doses of radiation following radiological/nuclear incident
Orphan Designation Status: Designated/Approved
Amgen Inc.
1 Amgen Center Drive
Thousand Oaks, California 91320
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: romiplostim
Trade Name: Nplate
Marketing Approval Date: 01/28/2021
Approved Labeled Indication: to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS])
Exclusivity End Date: 01/28/2028 
Exclusivity Protected Indication* :  to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS])
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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