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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Eflornithine HCl
Trade Name: Ornidyl
Date Designated: 04/23/1986
Orphan Designation: Treatment of Trypanosoma brucei gambiense infection (sleeping sickness).
Orphan Designation Status: Designated/Approved
Hoechst Marion Roussel
P.O. Box 9627
Kansas City, Missouri 64134
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Eflornithine HCl
Trade Name: Ornidyl
Marketing Approval Date: 11/28/1990
Approved Labeled Indication:
Exclusivity End Date: 11/28/1997 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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