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Epinephrine · Regulatory label update
U.S. Food and Drug Administration · June 22, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a regulatory labeling supplement approved by the FDA on 22 June 2026 for ADRENALIN (epinephrine). The record does not contain clinical trial results, efficacy data, or safety comparisons. The specific content of the labeling changes is not disclosed in this record.
Regulatory label update.
This is a regulatory labeling supplement approved by the FDA on 22 June 2026 for ADRENALIN (epinephrine). The record does not contain clinical trial results, efficacy data, or safety comparisons. The specific content of the labeling changes is not disclosed in this record.
No safety or comparative effectiveness information is provided.
The source did not state who this applies to in practice.
FDA supplemental approval for labeling changes to an established epinephrine product; does not report clinical trial outcomes or comparative efficacy 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 NDA204640. This is a regulatory action record, not a clinical study. Brand name: ADRENALIN. Active ingredient: EPINEPHRINE. Sponsor: PH HEALTH. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-22. Products: ADRENALIN, SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, EPINEPHRINE EQ 30MG BASE/30ML (EQ 1MG BASE/ML).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.