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 application for valproic acid on 31 March 2026, specifically a labeling change for the syrup formulation (250 mg/5 mL oral solution) manufactured by Lannett Co Inc. This regulatory record documents the approval action itself but does not contain clinical trial data, efficacy outcomes, or the rationale for the labeling modification.

What was studied

Regulatory label update.

Key findings

Safety

This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for valproic acid labeling; it documents a regulatory decision, not clinical trial evidence or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-03-31

FormulationVALPROIC ACID, SYRUP, ORAL, 250MG/5ML

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific nature of the labeling change is not disclosed in this record.
No indication, dosing modification, contraindication, or warning change is detailed.
This document confirms approval only; it does not support any clinical claim.

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

This is a regulatory record, not a clinical study with a design.

Directness

insufficient

Record does not report clinical outcomes or trial results.

Consistency

insufficient

No comparative or replication data provided in this record.

Risk of bias

insufficient

Regulatory action does not assess trial methodology or bias.

Sample adequacy

insufficient

No sample size or clinical study population reported.

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 ANDA077960. This is a regulatory action record, not a clinical study. Brand name: VALPROIC ACID. Active ingredient: VALPROIC ACID. Sponsor: LANNETT CO INC. 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.

Lannett COValproic Acid