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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: docosahexanoic acid-paclitaxel
Date Designated: 03/05/2001
Orphan Designation: Treatment of hormone-refractory prostate cancer.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 08/26/2015
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Luitpold Pharmaceuticals, Inc.
One Luitpold Drive
Shirley, New York 11976
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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