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Krintafel Approval History

FDA Approved: Yes (First approved July 20, 2018)
Brand name: Krintafel
Generic name: tafenoquine
Dosage form: Tablets
Company: GlaxoSmithKline
Treatment for: Malaria

Krintafel (tafenoquine) is an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

Development History and FDA Approval Process for Krintafel

DateArticle
Jan 16, 2019Two Positive Phase III studies of Tafenoquine for the Radical Cure of Plasmodium vivax Malaria Published in The New England Journal of Medicine
Jul 20, 2018Approval FDA Approves Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria
Jul 12, 2018FDA Advisory Committee Endorses the Effectiveness and Safety of Single-Dose Tafenoquine for the Radical Cure of P. vivax Malaria
Nov 28, 2017GSK Submits US Regulatory Application for Single-Dose Tafenoquine for Plasmodium vivax Malaria
Jun 12, 2017GSK and MMV Announce Positive Headline Phase III Results Showing Single-Dose Tafenoquine Reduces Risk of Relapse in Patients with Plasmodium vivax Malaria
Apr 28, 2014GSK and MMV Announce Start of Phase III Programme of Tafenoquine for Plasmodium vivax Malaria
Dec 20, 2013GSK and MMV Announce FDA Breakthrough Therapy Designation for Tafenoquine for Plasmodium vivax Malaria

Further information

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