Levetiracetam · Regulatory label update

FDA supplemental approval: Levetiracetam Solution (Labeling)

U.S. Food and Drug Administration · April 8, 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 regulatory record documenting FDA approval of a supplemental labeling change for levetiracetam solution (100 mg/mL oral formulation) by Chartwell Molecular on 8 April 2026. The record does not contain clinical trial results, efficacy data, or safety findings; it is an administrative action confirming label revision for an established generic antiepileptic drug.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling change to an established generic antiepileptic; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Product strength100 mg/mL

Approval date2026-04-08

Caveats

This record does not contain clinical trial results, efficacy data, or comparative safety evidence.
The nature and scope of the labeling change are not detailed in this regulatory record.
No information on patient populations, indications, dosing, or clinical outcomes 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 action; no clinical study design applicable.

Directness

insufficient

Labeling supplement; clinical outcomes not reported.

Consistency

insufficient

Single regulatory action; no comparative evidence provided.

Risk of bias

insufficient

Not a clinical trial; bias assessment not applicable.

Sample adequacy

insufficient

No patient sample; regulatory administrative record only.

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 ANDA090263. This is a regulatory action record, not a clinical study. Brand name: LEVETIRACETAM SOLUTION. Active ingredient: LEVETIRACETAM. Sponsor: CHARTWELL MOLECULAR. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-08. Products: LEVETIRACETAM, SOLUTION, ORAL, LEVETIRACETAM 100MG/ML.

Follow from this

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

LevetiracetamChartwell Molecular