Fosaprepitant Dimeglumine · Regulatory label update

FDA supplemental approval: Fosaprepitant (Labeling)

U.S. Food and Drug Administration · June 10, 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 action for fosaprepitant dimeglumine intravenous powder formulation (150 mg per vial), specifically a labeling update granted on 10 June 2026 by Chia Tai Tianqing. The record does not contain clinical trial results, efficacy data, or safety findings; it documents only the regulatory decision and product specifications.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory labeling supplement, not a clinical trial; no efficacy, safety, or comparative outcome data are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for fosaprepitant labeling; this is a regulatory action, not a clinical evidence record, and does not report trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approved product strengthFOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL

Approval date2026-06-10

Caveats

This is a regulatory labeling supplement, not a clinical trial; no efficacy, safety, or comparative outcome data are reported.
The record does not specify what labeling changes were made or the clinical rationale for them.
No trial design, sample size, endpoints, or statistical analysis are provided.
This approval action does not constitute evidence of clinical benefit or superior efficacy.

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 action record, not a clinical study.

Directness

insufficient

Regulatory approval record does not report clinical or efficacy data.

Consistency

insufficient

No comparative or outcome data provided in this labeling approval.

Risk of bias

insufficient

Not applicable to a regulatory labeling action record.

Sample adequacy

insufficient

No clinical trial 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 ANDA212143. This is a regulatory action record, not a clinical study. Brand name: FOSAPREPITANT. Active ingredient: FOSAPREPITANT DIMEGLUMINE. Sponsor: CHIA TAI TIANQING. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-10. Products: FOSAPREPITANT DIMEGLUMINE, POWDER, INTRAVENOUS, FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL.

Follow from this

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

Fosaprepitant DimeglumineChia TAI Tianqing