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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cintredekin besudotox
Date Designated: 11/02/2001
Orphan Designation: Treatment of malignant glioma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/02/2015
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Insys Development Company, Inc.
1333 South Sprectum Blvd, Suite 100
Chandler, Alaska 85286
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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