Lidocaine Hydrochloride · Regulatory label update

FDA supplemental approval: Lidocaine (Labeling)

U.S. Food and Drug Administration · August 17, 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 labeling change for lidocaine hydrochloride injectable formulations (2% and 4% preservative-free) manufactured by Fresenius Kabi USA on 17 August 2026. This record documents the regulatory action only and contains no information on clinical efficacy, safety data, or trial outcomes.

What was studied

Regulatory label update.

Key findings

Supplemental approval issued for lidocaine hydrochloride preservative-free injectable formulations at 2% and 4% concentrations Approval date: 17 August 2026 Sponsor: Fresenius Kabi USA

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval for lidocaine labeling changes; describes regulatory action only, not clinical efficacy or trial outcomes.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-08-17

NDA number017584

Caveats

This is a regulatory record and does not contain clinical trial results, efficacy data, or safety data.
The specific nature of the labeling changes is not detailed in this record.
No information is provided on the clinical evidence supporting the labeling change.
This approval does not convey comparative benefit or clinical superiority claims.

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

This is a regulatory action record, not a clinical study.

Directness

insufficient

Regulatory record does not report clinical trial data or patient outcomes.

Consistency

insufficient

No comparative or outcome data provided in this record.

Risk of bias

insufficient

Regulatory approval record does not assess bias in underlying evidence.

Sample adequacy

insufficient

No patient population or sample size data reported.

Source abstract

Drugs@FDA record for application NDA017584. This is a regulatory action record, not a clinical study. Brand name: LIDOCAINE. Active ingredient: LIDOCAINE HYDROCHLORIDE. Sponsor: FRESENIUS KABI USA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-17. Products: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, INJECTABLE, INJECTION, LIDOCAINE HYDROCHLORIDE 4%; LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, INJECTABLE, INJECTION, LIDOCAINE HYDROCHLORIDE 2%.

Follow from this

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

Fresenius Kabi ULidocaine Hydrochloride