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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sargramostim
Trade Name: Leukine
Date Designated: 11/09/2016
Orphan Designation: Treatment of individuals acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)
Orphan Designation Status: Designated/Approved
Partner Therapeutics, Inc.
19 Muzzey Street
Lexington, Massachusetts 02421
United States

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

Marketing approved:

1 Generic Name: sargramostim
Trade Name: Leukine
Marketing Approval Date: 03/29/2018
Approved Labeled Indication: LEUKINE® is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
Exclusivity End Date: 03/29/2025 
Exclusivity Protected Indication* :  to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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