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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Nine amino acid polypeptide derived from proteinase 3
Date Designated: 09/03/2004
Orphan Designation: Treatment of chronic myelogenous leukemia.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
The Vaccine Company
P. O. Box 93921
Carmel, California 93921
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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