Atovaquone AND Proguanil Hydrochloride · Regulatory label update

FDA supplemental approval: Malarone (Labeling)

U.S. Food and Drug Administration · June 10, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is a regulatory approval record documenting FDA acceptance of a supplemental labeling submission for Malarone (atovaquone and proguanil hydrochloride). The record does not contain clinical trial data, efficacy results, or clinical evidence; it only confirms the regulatory action and product specifications.

What was studied

Regulatory label update.

Key findings

Safety

This record documents a regulatory labeling action only and does not contain clinical trial results, efficacy data, or safety analyses.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of labeling changes for an existing antimalarial drug; regulatory action without clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-10

Pediatric formulation strengthATOVAQUONE 62.5MG + PROGUANIL HYDROCHLORIDE 25MG

Adult formulation strengthATOVAQUONE 250MG + PROGUANIL HYDROCHLORIDE 100MG

Caveats

This record documents a regulatory labeling action only and does not contain clinical trial results, efficacy data, or safety analyses.
The specific labeling changes approved are not detailed in the source text.
No clinical endpoints, comparators, or outcome data are reported.
This approval does not imply new clinical evidence; it may reflect administrative, manufacturing, or minor informational updates.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory labeling record; no clinical study design reported.

Directness

insufficient

Record is administrative; does not report clinical endpoints or trial outcomes.

Consistency

insufficient

No comparisons or conflicting results reported in this labeling action.

Risk of bias

insufficient

Regulatory record; risk of bias assessment not applicable.

Sample adequacy

insufficient

No study population or sample size reported in labeling supplement.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application NDA021078. This is a regulatory action record, not a clinical study. Brand name: MALARONE. Active ingredient: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE. Sponsor: GLAXOSMITHKLINE. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-10. Products: MALARONE PEDIATRIC, TABLET, ORAL, ATOVAQUONE 62.5MG + PROGUANIL HYDROCHLORIDE 25MG; MALARONE, TABLET, ORAL, ATOVAQUONE 250MG + PROGUANIL HYDROCHLORIDE 100MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Atovaquone AND Proguanil HydrochlorideGlaxosmithkline