GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria

Press release – Tuesday 28 November 2017

Read online at:
https://www.gsk.com/en-gb/media/press-releases/gsk-submits-us-regulatory-
application-for-single-dose-tafenoquine-for-plasmodium-vivax-malaria/

GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) today announced the submission of a new drug application (NDA) by GSK to the United States Food and Drug Administration (FDA), seeking approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older. If approved, tafenoquine would be the first new medicine for the prevention of relapse of P. vivax malaria in more than 60 years, potentially addressing the need for a single-dose and effective medicine for this debilitating disease.

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