Search Orphan Drug Designations and Approvals
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Generic Name: | Halofantrine | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | Halofantrine |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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