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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: 05/03/1990
Orphan Designation: Treatment of neutropenia associated with bone marrow transplant, for the treatment of graft failure and delay of engraftment, and for the promotion of early engraftment.
Orphan Designation Status: Designated/Approved
Immunex Corporation
51 University Street
Seattle, Washington 98101
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: 03/05/1991
Approved Labeled Indication:
Exclusivity End Date: 03/05/1998 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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