Valproic Acid · Regulatory label update

FDA supplemental approval: Valproic Acid (Labeling)

U.S. Food and Drug Administration · March 31, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental labeling change for valproic acid syrup 250 mg/5 mL manufactured by Chartwell Rx on 31 March 2026. This regulatory record documents the approval action only and contains no clinical trial data, efficacy measures, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This record is a regulatory action only and does not contain clinical trial results, efficacy data, or comparative safety information. No efficacy, safety, or clinical outcome data are available from this source.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of labeling for valproic acid syrup; this is a regulatory action record, not a clinical study, and does not contain efficacy or safety trial data.

Caveats

This record is a regulatory action only and does not contain clinical trial results, efficacy data, or comparative safety information.
The specific content and rationale of the labeling change are not detailed in this record.
No efficacy, safety, or clinical outcome data are available from this source.

Evidence assessment

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.

Study design

insufficient

Not applicable; this is a regulatory action, not a clinical study.

Directness

insufficient

Not applicable; no clinical outcome data reported in this record.

Consistency

insufficient

Not applicable; single regulatory record does not contain comparative data.

Risk of bias

insufficient

Not applicable; regulatory action record, not a clinical trial.

Sample adequacy

insufficient

Not applicable; no clinical sample reported in this record.

What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA075782. This is a regulatory action record, not a clinical study. Brand name: VALPROIC ACID. Active ingredient: VALPROIC ACID. Sponsor: CHARTWELL RX. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-03-31. Products: VALPROIC ACID, SYRUP, ORAL, VALPROIC ACID 250MG/5ML.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Chartwell RXValproic Acid