Levetiracetam · Regulatory label update

FDA supplemental approval: Levetiracetam (Labeling)

U.S. Food and Drug Administration · June 8, 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 labeling changes to levetiracetam extended-release tablets (500 mg and 750 mg formulations) on 8 June 2026, submitted by Aiping Pharm Inc. This record documents the regulatory action only and does not contain clinical trial results, safety data, or efficacy comparisons.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory record of a labeling supplement, not a clinical trial or safety/efficacy study. No clinical trial results, efficacy data, or safety outcomes are reported in this record.

Who this may help

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

Plain-language summary

This is an FDA supplemental approval for levetiracetam labeling; it documents a regulatory action, not a clinical trial, and does not report efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-08

Product strengths approved500 mg, 750 mg extended-release tablets

Caveats

This is a regulatory record of a labeling supplement, not a clinical trial or safety/efficacy study.
No clinical trial results, efficacy data, or safety outcomes are reported in this record.
The specific labeling changes made are not detailed in the source text.
No comparative benefit or clinical evidence 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 clinical study design present.

Directness

insufficient

Labeling supplement; no clinical outcome data reported.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Not applicable to regulatory labeling submission.

Sample adequacy

insufficient

Not applicable; no clinical trial population described.

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 ANDA204754. This is a regulatory action record, not a clinical study. Brand name: LEVETIRACETAM. Active ingredient: LEVETIRACETAM. Sponsor: AIPING PHARM INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-08. 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.

LevetiracetamAiping Pharm