Ciclopirox Olamine · Regulatory label update

FDA supplemental approval: Ciclopirox Olamine (Labeling)

U.S. Food and Drug Administration · July 29, 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 supplemental FDA approval for a labeling change to ciclopirox olamine 0.77% cream, a topical antifungal agent. The record documents a regulatory action only and does not contain clinical trial data, efficacy results, or safety outcomes. Clinicians should consult the approved labeling for any changes to indications, dosing, contraindications, or warnings.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental application ANDA076790 on 2026-07-29 for labeling change Product: ciclopirox olamine 0.77% cream, topical formulation

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes; it is a regulatory action notice only.

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 an existing topical antifungal; does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-29

Product strength0.77%

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes; it is a regulatory action notice only.
No information provided regarding specific labeling changes, indications, or clinical impact.
Efficacy, comparator data, and patient population are not reported in this regulatory document.
The nature of the labeling supplement (e.g., indication change, warning addition, dosing revision) is not specified.

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

No clinical endpoints or patient outcomes reported in this record.

Consistency

insufficient

No comparative data or prior results referenced in this approval notice.

Risk of bias

insufficient

Regulatory document; clinical trial methodology not described.

Sample adequacy

insufficient

No study population or sample size reported in this labeling record.

Source abstract

Drugs@FDA record for application ANDA076790. This is a regulatory action record, not a clinical study. Brand name: CICLOPIROX OLAMINE. Active ingredient: CICLOPIROX OLAMINE. Sponsor: SUN PHARMA CANADA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-29. Products: CICLOPIROX, CREAM, TOPICAL, CICLOPIROX 0.77%.

Follow from this

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

Ciclopirox OlamineSUN Pharma Canada