Itraconazole · Regulatory label update

FDA supplemental approval: Sporanox (Labeling)

U.S. Food and Drug Administration · July 7, 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 U.S. FDA supplemental approval action dated 2026-07-07 for a labeling change to itraconazole (Sporanox 100 mg oral capsule). The record documents the regulatory decision and does not contain clinical trial results, efficacy data, or safety findings; it indicates only that the FDA accepted and approved a labeling modification submitted by Janssen Pharmaceuticals.

What was studied

Regulatory label update. United States (FDA).

Key findings

Safety

This is a regulatory approval record only; it does not contain clinical trial results, efficacy outcomes, safety data, or details of the labeling change. No comparator, control arm, or comparative safety or efficacy information is provided.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling change to itraconazole; describes a regulatory action, not clinical evidence of efficacy or safety.

Study design

As stated by the source record.

SettingUnited States (FDA)

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-07

Drug and formulationItraconazole 100 mg oral capsule

Submission typeSupplemental labeling

Caveats

This is a regulatory approval record only; it does not contain clinical trial results, efficacy outcomes, safety data, or details of the labeling change.
The specific content of the labeling modification is not described in this record.
No comparator, control arm, or comparative safety or efficacy information is provided.
No information on patient population, indication, dosing, or clinical context for the change.

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 record; no clinical study design reported.

Directness

insufficient

Labeling action only; no clinical outcomes or trial data provided.

Consistency

insufficient

Single regulatory action; no comparative data or prior results cited.

Risk of bias

insufficient

Regulatory record does not assess or report bias in underlying evidence.

Sample adequacy

insufficient

No sample size or clinical population described in this record.

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 NDA020083. This is a regulatory action record, not a clinical study. Brand name: SPORANOX. Active ingredient: ITRACONAZOLE. Sponsor: JANSSEN PHARMS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-07. Products: SPORANOX, CAPSULE, ORAL, ITRACONAZOLE 100MG.

Follow from this

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

ItraconazoleJanssen Pharms