Edaravone · Regulatory approval

FDA approval: Edaravone

U.S. Food and Drug Administration · July 22, 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 edaravone 30 mg/100 mL intravenous solution as an original ANDA application by Zydus Pharmaceuticals on 22 July 2026. This is a regulatory authorization record and does not contain clinical trial results, efficacy data, or comparative safety information.

What was studied

Regulatory approval.

Key findings

Approval granted for edaravone 30 mg/100 mL intravenous solution formulation

Safety

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

Who this may help

This approval authorizes marketing of a generic or new formulation of edaravone but does not establish efficacy, safety, or comparative benefit for any clinical indication. Clinicians should refer to the established indication and safety profile of edaravone itself.

Plain-language summary

FDA approval of an generic intravenous edaravone formulation; represents regulatory authorization but does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-22

FormulationSOLUTION, INTRAVENOUS, 30MG/100ML (0.3MG/ML)

Application typeORIG (original application)

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety comparisons.
No indication, dosing schedule, or patient population is specified in this regulatory record.
Approval status does not imply or report comparative advantage over existing formulations.
The clinical evidence supporting edaravone's use is not included in this FDA action.

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 record, not a clinical study.

Directness

insufficient

Regulatory approval does not report clinical outcomes or patient-relevant endpoints.

Consistency

insufficient

No comparative data or multiple studies reported in this record.

Risk of bias

insufficient

This is an approval action, not a trial subject to bias assessment.

Sample adequacy

insufficient

No sample size or population data provided in regulatory record.

Source abstract

Drugs@FDA record for application ANDA218349. This is a regulatory action record, not a clinical study. Brand name: EDARAVONE. Active ingredient: EDARAVONE. Sponsor: ZYDUS PHARMS. Submission type: ORIG (original application). Approval status date: 2026-07-22. Products: EDARAVONE, SOLUTION, INTRAVENOUS, EDARAVONE 30MG/100ML (0.3MG/ML).

Follow from this

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

Zydus PharmsEdaravone