Levetiracetam · Regulatory approval

FDA approval: Levetiracetam IN Sodium Chloride

U.S. Food and Drug Administration · May 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 an FDA regulatory approval (ANDA) for a generic intravenous levetiracetam formulation in sodium chloride, issued on 8 May 2026 by Mylan Labs Ltd. The record confirms bioequivalence review and approval but does not contain clinical trial outcomes, efficacy data, or safety study results.

What was studied

Regulatory approval. Intervention: Levetiracetam in sodium chloride, intravenous formulations: 500 mg/100 mL (5 mg/mL), 1 g/100 mL (10 mg/mL), 1.5 g/100 mL (15 mg/mL).

Key findings

Three levetiracetam in sodium chloride intravenous formulations approved: 500 mg/100 mL (5 mg/mL), 1 g/100 mL (10 mg/mL), and 1.5 g/100 mL (15 mg/mL)

Safety

This record contains no clinical trial data, efficacy outcomes, or comparative safety findings. No information on contraindications, adverse events, or dosing recommendations is provided in this regulatory record.

Who this may help

Clinicians should know this generic formulation has met FDA bioequivalence standards for intravenous levetiracetam. This approval does not provide new efficacy or comparative safety data; clinical use follows the reference product's established indications.

Plain-language summary

FDA approval of a generic intravenous levetiracetam formulation; regulatory action, not a clinical trial or efficacy study.

Study design

As stated by the source record.

InterventionLevetiracetam in sodium chloride, intravenous formulations: 500 mg/100 mL (5 mg/mL), 1 g/100 mL (10 mg/mL), 1.5 g/100 mL (15 mg/mL)

Reported figures

Quoted from the source exactly as published.

Approval status date2026-05-08

Application typeANDA218364 (original)

Clinical bottom line

Caveats

This record contains no clinical trial data, efficacy outcomes, or comparative safety findings.
Approval is based on bioequivalence review; clinical efficacy was not re-evaluated in this ANDA.
No information on contraindications, adverse events, or dosing recommendations is provided in this regulatory record.
The source does not report which reference product was used for bioequivalence comparison.

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 approval record; no clinical study design reported.

Directness

insufficient

This is a regulatory action, not a clinical trial with outcome data.

Consistency

insufficient

No comparative efficacy or safety data presented in this record.

Risk of bias

insufficient

Regulatory approval record does not contain clinical trial methodology.

Sample adequacy

insufficient

No study population or sample size reported in this approval notice.

Source abstract

Drugs@FDA record for application ANDA218364. This is a regulatory action record, not a clinical study. Brand name: LEVETIRACETAM IN SODIUM CHLORIDE. Active ingredient: LEVETIRACETAM. Sponsor: MYLAN LABS LTD. Submission type: ORIG (original application). Approval status date: 2026-05-08. Products: LEVETIRACETAM IN SODIUM CHLORIDE, INJECTABLE, INTRAVENOUS, LEVETIRACETAM 1.5GM/100ML (15MG/ML); LEVETIRACETAM IN SODIUM CHLORIDE, INJECTABLE, INTRAVENOUS, LEVETIRACETAM 500MG/100ML (5MG/ML); LEVETIRACETAM IN SODIUM CHLORIDE, INJECTABLE, INTRAVENOUS, LEVETIRACETAM 1GM/100ML (10MG/ML).

Follow from this

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

Mylan LabsLevetiracetam