Filgrastim · Regulatory label update

FDA supplemental approval: Neupogen (Labeling)

U.S. Food and Drug Administration · July 16, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a U.S. FDA supplemental approval (labeling change) for Neupogen (filgrastim) issued 16 July 2026. The record indicates a labeling modification to existing products across four formulations and strengths, but contains no clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update. Intervention: Labeling supplement for Neupogen (filgrastim) across four formulations: 300 mcg/0.5 mL syringe, 300 mcg/1 mL vial, 480 mcg/0.8 mL syringe, 480 mcg/1.6 mL vial. United States (FDA).

Key findings

Supplemental approval granted for labeling changes to Neupogen (filgrastim) on 2026-07-16

Safety

This is a regulatory record only; no clinical trial results, efficacy data, or safety study findings are reported.

Who this may help

This record documents a regulatory action but does not contain clinical evidence. Clinicians should consult the updated product labeling issued by FDA for details on indications, dosing, contraindications, or safety information affected by this supplement.

Plain-language summary

FDA supplemental approval for labeling changes to an established drug; does not report clinical trial data or efficacy evidence.

Study design

As stated by the source record.

InterventionLabeling supplement for Neupogen (filgrastim) across four formulations: 300 mcg/0.5 mL syringe, 300 mcg/1 mL vial, 480 mcg/0.8 mL syringe, 480 mcg/1.6 mL vial

SettingUnited States (FDA)

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-16

Clinical bottom line

Caveats

This is a regulatory record only; no clinical trial results, efficacy data, or safety study findings are reported.
The specific content of the labeling changes is not disclosed in this record.
No comparative data, outcomes, or clinical endpoints are available.
Strength and formulation details are listed but no clinical context or rationale is provided.

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 record; no clinical study design present.

Directness

insufficient

Labeling supplement; no clinical outcome data reported.

Consistency

insufficient

No comparative or replication data in regulatory record.

Risk of bias

insufficient

Regulatory record does not assess or report bias metrics.

Sample adequacy

insufficient

No study population or sample size; labeling action only.

Source abstract

Drugs@FDA record for application BLA103353. This is a regulatory action record, not a clinical study. Brand name: NEUPOGEN. Active ingredient: FILGRASTIM. Sponsor: AMGEN. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-16. Products: NEUPOGEN, SYRINGE, FILGRASTIM 300MGC/0.5ML; NEUPOGEN, VIAL, FILGRASTIM 300MCG/1ML; NEUPOGEN, SYRINGE, FILGRASTIM 480MCG/0.8ML; NEUPOGEN, VIAL, FILGRASTIM 480MCG/1.6ML.

Follow from this

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

FilgrastimAmgen