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 regulatory approval record documenting an FDA supplemental labeling change for lidocaine hydrochloride and epinephrine (ANDA089644), approved 1 April 2026. The record does not contain clinical trial results, efficacy data, or safety outcomes; it documents only the labeling submission type and product specification.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for labeling of lidocaine hydrochloride and epinephrine injectable combination Product formulation: epinephrine 0.01 mg/mL + lidocaine hydrochloride 1%

Safety

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

Who this may help

This labeling supplement does not provide clinical evidence on efficacy, safety, or comparative benefit. Clinicians should consult the updated label and full prescribing information for any changes to indications, dosing, contraindications, or warnings.

Plain-language summary

FDA supplemental approval for labeling changes to an established local anesthetic combination; does not report clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-01

Epinephrine concentration0.01 mg/mL

Lidocaine hydrochloride concentration1%

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes
The nature of labeling changes is not specified in the record
No prior trial evidence, population data, or comparative effectiveness information is reported

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 record; no clinical study design reported.

Directness

insufficient

Record does not describe clinical outcomes or trial endpoints.

Consistency

insufficient

No comparative data or previous trial results referenced in record.

Risk of bias

insufficient

Regulatory action; assessment of clinical study bias not applicable.

Sample adequacy

insufficient

No clinical trial population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA089644. 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 0.01MG/ML + LIDOCAINE HYDROCHLORIDE 1%.

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