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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mefloquine HCL
Trade Name: Lariam
Date Designated: 04/13/1988
Orphan Designation: For use in the treatment of acute malaria due to Plasmodium falciparum and Plasmodium vivax, and for the prophylaxis of Plasmodium falciparum malaria which is resistant to other available drugs
Orphan Designation Status: Designated/Approved/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/18/2024
Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley, New Jersey 07110
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
1 Generic Name: mefloquine HCL
Trade Name: Lariam
Marketing Approval Date: 05/02/1989
Approved Labeled Indication: Treatment of acute malaria due to Plasmodium falciparum and Plasmodium vivax
Exclusivity End Date: 05/02/1996 
2 Generic Name: mefloquine HCL
Trade Name: Lariam
Marketing Approval Date: 05/03/1989
Approved Labeled Indication: Prophylaxis of Plasmodium falciparum malaria which is resistant to other available drugs
Exclusivity End Date: 05/03/1996 
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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