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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: (4S)-4-ethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1-H-pyrano[3?,4?:6,7]-indolizino-[1,2-b]-quinoline-11-carbaldehyde O-(tert-butyl)-(E)-oxime
Date Designated: 11/29/2002
Orphan Designation: Treatment malignant glioma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sigma-Tau Research, Inc.
9841 Washingtonian Blvd
Suite 502
Gaithersburg, Maryland 20878
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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