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Fenofibrate · Regulatory label update
U.S. Food and Drug Administration · August 17, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a regulatory record documenting FDA supplemental approval of a labeling change for fenofibrate (145 mg and 48 mg tablets) on 2026-08-17. The record does not contain clinical trial results, efficacy data, or comparative evidence; it is an administrative action by the sponsor Rising Pharmaceuticals.
Regulatory label update.
This is a regulatory record documenting FDA supplemental approval of a labeling change for fenofibrate (145 mg and 48 mg tablets) on 2026-08-17. The record does not contain clinical trial results, efficacy data, or comparative evidence; it is an administrative action by the sponsor Rising Pharmaceuticals.
No safety or efficacy evidence is reported; regulatory action does not imply new clinical evidence.
The source did not state who this applies to in practice.
FDA supplemental approval for fenofibrate labeling change; describes a regulatory action, not clinical efficacy or comparative trial 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 ANDA211122. This is a regulatory action record, not a clinical study. Brand name: FENOFIBRATE. Active ingredient: FENOFIBRATE. Sponsor: RISING. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-17. Products: FENOFIBRATE, TABLET, ORAL, FENOFIBRATE 145MG; FENOFIBRATE, TABLET, ORAL, FENOFIBRATE 48MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.