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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: 03/06/1995
Orphan Designation: To reduce neutropenia and leukopenia and decrease the incidence of death due to infection in patients with acute myelogenous leukemia.
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: 09/15/1995
Approved Labeled Indication: Following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death.
Exclusivity End Date: 09/15/2002 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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