Heparin Sodium · Regulatory label update

FDA supplemental approval: Heparin Sodium (Labeling)

U.S. Food and Drug Administration · July 13, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval record for labeling changes to heparin sodium injectable products (1,000, 5,000, and 10,000 units/mL formulations) by Hospira Inc., approved on 13 July 2026. The record documents a regulatory action only and does not contain clinical trial data, efficacy results, or comparative clinical evidence.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory record, not a clinical trial; no efficacy, safety, or comparative outcome data are reported. No information on indication, dosing changes, contraindications, or safety signals is given in the source text.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for heparin sodium injectable formulations; this is a regulatory action, not a clinical efficacy study.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-13

SponsorHOSPIRA INC.

Application numberANDA090571

Caveats

This is a regulatory record, not a clinical trial; no efficacy, safety, or comparative outcome data are reported.
Labeling submission class indicates documentation update only; specific labeling changes are not detailed in this record.
No clinical trial results, sample size, or statistical evidence are provided.
No information on indication, dosing changes, contraindications, or safety signals is given in the source text.

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; no clinical study design reported.

Directness

insufficient

Labeling action only; clinical outcomes not reported.

Consistency

insufficient

No comparative data or prior trials referenced in record.

Risk of bias

insufficient

Regulatory approval process; trial bias assessment not applicable.

Sample adequacy

insufficient

No clinical trial sample size reported in labeling record.

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 ANDA090571. This is a regulatory action record, not a clinical study. Brand name: HEPARIN SODIUM. Active ingredient: HEPARIN SODIUM. Sponsor: HOSPIRA INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-13. Products: HEPARIN SODIUM, INJECTABLE, INJECTION, HEPARIN SODIUM 10,000 UNITS/ML; HEPARIN SODIUM, INJECTABLE, INJECTION, HEPARIN SODIUM 1,000 UNITS/ML; HEPARIN SODIUM, INJECTABLE, INJECTION, HEPARIN SODIUM 5,000 UNITS/ML.

Follow from this

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

Heparin SodiumHospira