Fenofibric Acid · Regulatory label update

FDA supplemental approval: Fenofibric Acid (Labeling)

U.S. Food and Drug Administration · July 13, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This record documents an FDA supplemental approval for a labeling change to fenofibric acid capsules (delayed-release formulation, 45 mg and 135 mg strengths) submitted by Macleods Pharmaceuticals, effective 13 July 2026. The record itself does not contain clinical trial data, efficacy results, or safety findings; it is solely a regulatory action reflecting approval of labeling modifications.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety findings. No information on the basis for the labeling supplement (e.g., new indication, safety update, manufacturing change) is provided.

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for labeling of fenofibric acid; it documents a regulatory decision, not clinical evidence of efficacy or safety.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-13

Strength 1135 mg (choline fenofibrate equivalent)

Strength 245 mg (choline fenofibrate equivalent)

Caveats

This record does not contain clinical trial results, efficacy data, or safety findings.
The specific labeling changes requested or approved are not detailed in this record.
No information on the basis for the labeling supplement (e.g., new indication, safety update, manufacturing change) is provided.
This is an ANDA supplemental submission; the original approval date and trial evidence supporting the product are not reported here.

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

This is a regulatory action, not a clinical study with a design.

Directness

insufficient

Regulatory record does not report clinical trial outcomes or direct evidence.

Consistency

insufficient

No comparative data or consistency assessment reported in this record.

Risk of bias

insufficient

Risk of bias assessment does not apply to labeling approval records.

Sample adequacy

insufficient

No clinical trial population or sample size reported 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 ANDA207796. This is a regulatory action record, not a clinical study. Brand name: FENOFIBRIC ACID. Active ingredient: FENOFIBRIC ACID. Sponsor: MACLEODS PHARMS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-13. Products: FENOFIBRIC ACID, CAPSULE, DELAYED RELEASE, ORAL, CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID; FENOFIBRIC ACID, CAPSULE, DELAYED RELEASE, ORAL, CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID.

Follow from this

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

Macleods PharmsFenofibric Acid