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Linezolid · Regulatory label update
U.S. Food and Drug Administration · June 9, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a regulatory action record documenting FDA approval of a supplemental labeling change for linezolid (Hospira, NDA 206473) as a 600 mg/300 mL intravenous solution in sodium chloride 0.9%. The record does not contain clinical trial data, efficacy outcomes, or comparative safety information.
Regulatory label update.
This is a regulatory action record documenting FDA approval of a supplemental labeling change for linezolid (Hospira, NDA 206473) as a 600 mg/300 mL intravenous solution in sodium chloride 0.9%. The record does not contain clinical trial data, efficacy outcomes, or comparative safety information.
This record does not contain clinical trial results, efficacy data, or comparative safety outcomes.
The source did not state who this applies to in practice.
FDA supplemental approval for linezolid labeling change; 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 NDA206473. This is a regulatory action record, not a clinical study. Brand name: LINEZOLID. Active ingredient: LINEZOLID. Sponsor: HOSPIRA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-09. Products: LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SOLUTION, INTRAVENOUS, LINEZOLID 600MG/300ML (2MG/ML).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.