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

This is an FDA supplemental approval action for a labeling change to valproic acid syrup (250 mg/5 mL, ANDA074060, sponsored by Hikma). The record documents regulatory authorization only and does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or comparative safety information.

Who this may help

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

Plain-language summary

FDA supplemental approval for valproic acid labeling change; regulatory action only, no clinical trial data or efficacy evidence provided.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-03-31

Product formulationVALPROIC ACID, SYRUP, ORAL, VALPROIC ACID 250MG/5ML

Caveats

This record does not contain clinical trial results, efficacy data, or comparative safety information.
The specific labeling change approved is not described in this regulatory notification.
No participant data, endpoints, or outcome measures are reported.
Approval date is in the future (2026-03-31), suggesting this may be a projected or template record.

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

Regulatory action record; no study design present.

Directness

insufficient

Labeling supplement; clinical outcome data not reported.

Consistency

insufficient

Single regulatory action; no comparative data or replication.

Risk of bias

insufficient

Not a clinical study; bias assessment not applicable.

Sample adequacy

insufficient

Regulatory approval; no participant enrollment or sample size.

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

Source abstract

Drugs@FDA record for application ANDA074060. This is a regulatory action record, not a clinical study. Brand name: VALPROIC ACID. Active ingredient: VALPROIC ACID. Sponsor: HIKMA. 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.

HikmaValproic Acid