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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Halofantrine
Trade Name: Halfan
Date Designated: 11/04/1991
Orphan Designation: Treatment of mild to moderate acute malaria caused by susceptible strains of P. falciparum and P. vivax.
Orphan Designation Status: Designated/Approved
SmithKline Beecham Pharmaceuticals
One Franklin Plaza
P.O. Box 7929
Philadelphia, Pennsylvania 19101
United States

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

Marketing approved:

1 Generic Name: Halofantrine
Trade Name: Halfan
Marketing Approval Date: 07/24/1992
Approved Labeled Indication: Treatment of adults who can tolerate oral medication and who have mild to moderate malaria caused by Plasmodium falciparum or Plasmodium vivax.
Exclusivity End Date: 07/24/1999 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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