Epinephrine · Regulatory approval

FDA approval: Epinephrine (New Combination and New Formulation or New Manufacturer)

U.S. Food and Drug Administration · March 30, 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 new formulation and manufacturer of epinephrine (Baxter HealthCare Corp) for intramuscular, intravenous, and subcutaneous routes, in two strengths (30 mg/30 mL and 1 mg/mL). This regulatory action permits marketing but does not constitute clinical evidence of efficacy, safety comparative benefit, or superiority over existing epinephrine products.

What was studied

Regulatory approval. Intervention: Epinephrine solution, 30 mg/30 mL (1 mg/mL) and 1 mg/mL formulations, for intramuscular, intravenous, and subcutaneous administration..

Key findings

Approval date: 2026-03-30 Sponsor: Baxter HealthCare Corp Approved formulations: 30 mg/30 mL (1 mg/mL) and 1 mg/mL solutions

Safety

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

Who this may help

This approval permits use of a new epinephrine formulation and manufacturer but does not provide clinical evidence to guide therapy selection or outcomes. Clinicians should apply existing epinephrine guidance; this record documents regulatory compliance, not therapeutic innovation.

Plain-language summary

FDA approval of a new formulation and manufacturer of epinephrine; this is a regulatory action, not a clinical efficacy study, and does not establish comparative clinical benefit.

Study design

As stated by the source record.

InterventionEpinephrine solution, 30 mg/30 mL (1 mg/mL) and 1 mg/mL formulations, for intramuscular, intravenous, and subcutaneous administration.

Reported figures

Quoted from the source exactly as published.

Approval date2026-03-30

Formulation 1 concentration30 mg/30 mL (1 mg/mL)

Formulation 2 concentration1 mg/mL

Clinical bottom line

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety comparative evidence.
No information on whether this formulation differs clinically from existing epinephrine products.
Approval status does not imply superiority or additional benefit over current standard formulations.
Study population, sample size, and clinical outcomes are not 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

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

Directness

insufficient

Record does not report clinical outcomes or efficacy data.

Consistency

insufficient

No comparative or outcome data provided in this regulatory record.

Risk of bias

insufficient

Regulatory approval does not constitute a controlled clinical assessment.

Sample adequacy

insufficient

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

Source abstract

Drugs@FDA record for application NDA220626. This is a regulatory action record, not a clinical study. Brand name: EPINEPHRINE. Active ingredient: EPINEPHRINE. Sponsor: BAXTER HLTHCARE CORP. Submission type: ORIG (original application). Submission class: New Combination and New Formulation or New Manufacturer. Approval status date: 2026-03-30. Products: EPINEPHRINE, SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, EPINEPHRINE 30MG/30ML (1MG/ML); EPINEPHRINE, SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, EPINEPHRINE 1MG/ML (1MG/ML).

Follow from this

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

EpinephrineBaxter Hlthcare