Ruxolitinib · Regulatory label update

FDA supplemental approval: Opzelura (Labeling)

U.S. Food and Drug Administration · June 30, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval record for a labeling change to Opzelura (ruxolitinib 1.5% cream), approved on 30 June 2026. The record documents the regulatory action itself but does not contain clinical trial data, efficacy results, or safety information; it is not evidence of clinical benefit or harm.

What was studied

Regulatory label update. Intervention: Ruxolitinib phosphate 1.5% cream, topical.

Key findings

Safety

This is a regulatory action record, not a clinical trial. No efficacy, safety, or comparative outcome data are reported. The record does not permit inference of clinical efficacy, safety profile, or superiority versus comparators.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling for an already-approved topical ruxolitinib cream; this record documents a regulatory action, not clinical trial evidence.

Study design

As stated by the source record.

InterventionRuxolitinib phosphate 1.5% cream, topical

Caveats

This is a regulatory action record, not a clinical trial. No efficacy, safety, or comparative outcome data are reported.
The specific labeling changes requested or approved are not detailed in this record.
No patient population, sample size, or clinical endpoints are provided.
The record does not permit inference of clinical efficacy, safety profile, or superiority versus comparators.

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 action record; no clinical study design reported.

Directness

insufficient

Labeling supplement; no clinical outcome data provided in this record.

Consistency

insufficient

Single regulatory decision; consistency with prior trials not discussed.

Risk of bias

insufficient

Regulatory record; risk of bias assessment not applicable or reported.

Sample adequacy

insufficient

No patient sample data in this regulatory labeling submission record.

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

Source abstract

Drugs@FDA record for application NDA215309. This is a regulatory action record, not a clinical study. Brand name: OPZELURA. Active ingredient: RUXOLITINIB. Sponsor: INCYTE CORP. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-30. Products: OPZELURA, CREAM, TOPICAL, RUXOLITINIB PHOSPHATE EQ 1.5% BASE.

Follow from this

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

RuxolitinibIncyte