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Furosemide · Regulatory label update
U.S. Food and Drug Administration · June 2, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA approved a supplemental labeling change for furosemide tablets (20 mg, 40 mg, and 80 mg) on 2 June 2026. This is a regulatory action that modifies product labeling; it does not report clinical trial results, efficacy data, or comparative evidence.
Regulatory label update.
The FDA approved a supplemental labeling change for furosemide tablets (20 mg, 40 mg, and 80 mg) on 2 June 2026. This is a regulatory action that modifies product labeling; it does not report clinical trial results, efficacy data, or comparative evidence.
This record is a regulatory action and does not contain clinical trial results, efficacy data, safety trial outcomes, or comparative evidence.
The source did not state who this applies to in practice.
FDA supplemental approval for labeling changes to furosemide; regulatory action without clinical trial data or efficacy claims.
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 NDA018569. This is a regulatory action record, not a clinical study. Brand name: FUROSEMIDE. Active ingredient: FUROSEMIDE. Sponsor: EPIC PHARMA LLC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-02. Products: FUROSEMIDE, TABLET, ORAL, FUROSEMIDE 40MG; FUROSEMIDE, TABLET, ORAL, FUROSEMIDE 20MG; FUROSEMIDE, TABLET, ORAL, FUROSEMIDE 80MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.