The panel backed the efficacy of the tafenoquine regimen by 13 votes to zero, and its safety by 12 to one, in P. vivax-infected patients aged 16 or older, after the FDA published briefing documents (PDF) which backed the drug.
Armed with new phase III data, GlaxoSmithKline is planning regulatory filings for its one-dose antimalarial tafenoquine, which is designed to prevent relapses in patients infected with the parasite.
Ingenus Pharms' Generic Primaquine Phosphate Approved in US
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