Levetiracetam · Regulatory label update

FDA supplemental approval: Levetiracetam (Labeling)

U.S. Food and Drug Administration · April 9, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a U.S. FDA supplemental approval record for levetiracetam extended-release tablets (500 mg and 750 mg) submitted by Chartwell RX on a labeling classification. The record documents regulatory action only and does not report clinical trial results, efficacy data, or comparative outcomes.

What was studied

Regulatory label update. United States (FDA).

Key findings

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information. No information on indication, dosing rationale, or clinical pharmacology supporting the approval is provided.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling changes to levetiracetam extended-release formulations; does not report clinical trial outcomes or comparative efficacy.

Study design

As stated by the source record.

SettingUnited States (FDA)

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-09

Formulations approvedExtended-release tablets, 500 mg and 750 mg

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information.
Labeling changes are noted but their specific content is not described in the source.
No information on indication, dosing rationale, or clinical pharmacology supporting the approval is provided.

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 record; no study design reported.

Directness

insufficient

Labeling action; clinical outcomes and direct evidence not described.

Consistency

insufficient

No comparative data or consistency assessment provided.

Risk of bias

insufficient

Regulatory approval; study quality metrics not applicable or reported.

Sample adequacy

insufficient

No trial sample size or population data 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 ANDA091291. This is a regulatory action record, not a clinical study. Brand name: LEVETIRACETAM. Active ingredient: LEVETIRACETAM. Sponsor: CHARTWELL RX. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-09. Products: LEVETIRACETAM, TABLET, EXTENDED RELEASE, ORAL, LEVETIRACETAM 750MG; LEVETIRACETAM, TABLET, EXTENDED RELEASE, ORAL, LEVETIRACETAM 500MG.

Follow from this

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

LevetiracetamChartwell RX