Lidocaine Hydrochloride AND Epinephrine · Regulatory label update

FDA supplemental approval: Lidocaine Hydrochloride AND Epinephrine (Labeling)

U.S. Food and Drug Administration · April 1, 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 U.S. FDA supplemental approval for a labeling change to lidocaine hydrochloride and epinephrine injection (Hospira). The action is regulatory and administrative; it does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

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

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 a long-established local anesthetic combination; does not report clinical trial data or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-01

Product formulationEpinephrine 0.005 mg/mL + Lidocaine hydrochloride 2%

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific labeling change and its rationale are not detailed in this record.
No comparative data or clinical evidence is reported.
Approval does not imply new clinical benefit; supplement may address manufacturing, formulation, or administrative updates only.

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 applies.

Directness

insufficient

Labeling action; clinical outcomes not reported.

Consistency

insufficient

Single regulatory submission; no comparative data provided.

Risk of bias

insufficient

Regulatory record does not assess clinical trial bias.

Sample adequacy

insufficient

No trial population or sample size reported.

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 ANDA089651. This is a regulatory action record, not a clinical study. Brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE. Active ingredient: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE. Sponsor: HOSPIRA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-01. Products: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, INJECTABLE, INJECTION, EPINEPHRINE 0.005MG/ML + 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.

Lidocaine Hydrochloride AND EpinephrineHospira