JUN 10, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Malarone (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval of labeling changes for an existing antimalarial drug; regulatory action without clinical trial data.
Reported
Approval status date2026-06-10
Pediatric formulation strengthATOVAQUONE 62.5MG + PROGUANIL HYDROCHLORIDE…
Adult formulation strengthATOVAQUONE 250MG + PROGUANIL HYDROCHLORIDE…