Levetiracetam · Regulatory approval

FDA approval: Levetiracetam

U.S. Food and Drug Administration · August 6, 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 an intravenous formulation of levetiracetam 500 mg/5 mL (100 mg/mL) by Baxter Healthcare Corporation on 6 August 2026. This is a regulatory action record that establishes authorization for marketing; it does not contain clinical efficacy or safety trial data.

What was studied

Regulatory approval. Intervention: Levetiracetam, injectable, intravenous, 500 mg/5 mL (100 mg/mL).

Key findings

Approval granted for levetiracetam injectable, intravenous, 500 mg/5 mL (100 mg/mL) formulation

Safety

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

Who this may help

This record documents regulatory authorization of an IV levetiracetam product. Clinicians should consult the approved label, prescribing information, and supporting clinical literature for efficacy, safety, and dosing guidance; this record alone does not provide clinical evidence.

Plain-language summary

FDA approval of an intravenous levetiracetam formulation; establishes regulatory authorization but does not report clinical trial data or efficacy outcomes.

Study design

As stated by the source record.

InterventionLevetiracetam, injectable, intravenous, 500 mg/5 mL (100 mg/mL)

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-06

Formulation strength500 mg/5 mL (100 mg/mL)

Clinical bottom line

Caveats

This is a regulatory approval record and does not contain clinical trial results, efficacy data, or safety outcomes.
No information on indication, patient population, or clinical comparators is provided.
The record does not report sample size, endpoints, or statistical analyses.

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 reported.

Directness

insufficient

Record does not contain clinical outcome data or trial results.

Consistency

insufficient

No comparative data or replication data provided.

Risk of bias

insufficient

Regulatory approval record; clinical trial methodology not described.

Sample adequacy

insufficient

No sample size or trial population data reported.

Source abstract

Drugs@FDA record for application ANDA208458. This is a regulatory action record, not a clinical study. Brand name: LEVETIRACETAM. Active ingredient: LEVETIRACETAM. Sponsor: BAXTER HLTHCARE CORP. Submission type: ORIG (original application). Approval status date: 2026-08-06. Products: LEVETIRACETAM, INJECTABLE, INTRAVENOUS, LEVETIRACETAM 500MG/5ML (100MG/ML).

Follow from this

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

LevetiracetamBaxter Hlthcare