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Fenofibrate · Regulatory label update
U.S. Food and Drug Administration · August 5, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval action for a labeling change to fenofibrate tablets (40 mg and 120 mg oral formulations) by Mylan Pharmaceuticals. The record documents regulatory authorization only and does not contain clinical trial data, efficacy outcomes, or safety findings.
Regulatory label update.
This is an FDA supplemental approval action for a labeling change to fenofibrate tablets (40 mg and 120 mg oral formulations) by Mylan Pharmaceuticals. The record documents regulatory authorization only and does not contain clinical trial data, efficacy outcomes, or safety findings.
This record documents a regulatory action only and does not contain clinical trial results, efficacy data, or safety outcomes.
The source did not state who this applies to in practice.
FDA supplemental approval for fenofibrate labeling change; this is a regulatory action record, not a clinical trial, and does not report efficacy or safety data.
Quoted from the source exactly as published.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA204475. This is a regulatory action record, not a clinical study. Brand name: FENOFIBRATE. Active ingredient: FENOFIBRATE. Sponsor: MYLAN PHARMS INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-05. Products: FENOFIBRATE, TABLET, ORAL, FENOFIBRATE 40MG; FENOFIBRATE, TABLET, ORAL, FENOFIBRATE 120MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.