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Valproic Acid · Regulatory label update
U.S. Food and Drug Administration · April 17, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval action for a labeling change to valproic acid oral syrup (250 mg/5 mL) submitted by QUAGEN. The record documents regulatory authorization only and contains no clinical trial results, efficacy data, or safety findings.
Regulatory label update.
This is an FDA supplemental approval action for a labeling change to valproic acid oral syrup (250 mg/5 mL) submitted by QUAGEN. The record documents regulatory authorization only and contains no clinical trial results, efficacy data, or safety findings.
This record does not contain clinical trial results, efficacy data, or safety outcomes. This record documents approval only; it does not indicate the clinical or pharmacological basis for the labeling modification.
The source did not state who this applies to in practice.
FDA supplemental approval for valproic acid labeling change; no clinical trial data reported in this regulatory action record.
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 ANDA090517. This is a regulatory action record, not a clinical study. Brand name: VALPROIC ACID. Active ingredient: VALPROIC ACID. Sponsor: QUAGEN. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-17. Products: VALPROIC ACID, SYRUP, ORAL, VALPROIC ACID 250MG/5ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.