Lorazepam · Regulatory label update

FDA supplemental approval: Lorazepam (Labeling)

U.S. Food and Drug Administration · May 15, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This record documents an FDA supplemental approval for lorazepam injectable formulations (2 mg/mL and 4 mg/mL) on 15 May 2026, restricted to labeling changes. The record is administrative and does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This 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

This is an FDA supplemental approval action for lorazepam labeling; it documents a regulatory decision, not clinical evidence of efficacy or safety.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-15

Product strengths approved2 mg/mL and 4 mg/mL injectable formulations

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific labeling changes made are not detailed in this regulatory record.
No information is provided on the basis for approval (prior trial data or post-approval commitments are not stated).
This is an approval of a labeling supplement, not a new drug application or indication.

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 with a design.

Directness

insufficient

Labeling supplement; does not report clinical trial outcomes or direct evidence.

Consistency

insufficient

No comparative or outcome data provided in this approval record.

Risk of bias

insufficient

Not applicable to a regulatory labeling action; no trial conduct described.

Sample adequacy

insufficient

No clinical population or sample size reported in this labeling supplement.

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 ANDA200542. This is a regulatory action record, not a clinical study. Brand name: LORAZEPAM. Active ingredient: LORAZEPAM. Sponsor: RISING. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-15. Products: LORAZEPAM, INJECTABLE, INJECTION, LORAZEPAM 2MG/ML; LORAZEPAM, INJECTABLE, INJECTION, LORAZEPAM 4MG/ML.

Follow from this

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

RisingLorazepam