Cytarabine · Regulatory label update

FDA supplemental approval: Cytarabine (Labeling)

U.S. Food and Drug Administration · July 29, 2026

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AI Summary

This is an FDA supplemental approval for a labeling change to cytarabine injectable (20 mg/mL) manufactured by Hospira, approved on 29 July 2026. The record documents a regulatory action only and does not include clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval for cytarabine labeling update; regulatory action does not contain clinical trial efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-29

Product strengthCYTARABINE 20MG/ML

Caveats

This is a regulatory approval record that does not contain clinical trial results, efficacy outcomes, or safety data.
The specific labeling changes requested or approved are not described in this record.
No study design, sample size, or comparative analysis is available.
This record alone does not support clinical recommendations or practice guidance.

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 labeling record; no study design reported.

Directness

insufficient

Labeling submission; no clinical outcome data provided.

Consistency

insufficient

Single regulatory action; no comparison or consistency assessment.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable.

Sample adequacy

insufficient

No study 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 ANDA071868. This is a regulatory action record, not a clinical study. Brand name: CYTARABINE. Active ingredient: CYTARABINE. Sponsor: HOSPIRA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-29. Products: CYTARABINE, INJECTABLE, INJECTION, CYTARABINE 20MG/ML.

Follow from this

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

HospiraCytarabine