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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tafenoquine
Trade Name: Krintafel
Date Designated: 01/15/2013
Orphan Designation: Treatment of malaria
Orphan Designation Status: Designated/Approved
GlaxoSmithKline Intellectual Property Development Ltd. England
980 Great West Road
Brentford, Middlesex, England
United Kingdom

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

Marketing approved:

1 Generic Name: tafenoquine
Trade Name: Krintafel
Marketing Approval Date: 07/20/2018
Approved Labeled Indication: KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.
Exclusivity End Date: 07/20/2025 
Exclusivity Protected Indication* :  KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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