Sugammadex · Regulatory approval

FDA approval: Sugammadex

U.S. Food and Drug Administration · July 28, 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 FDA approval of sugammadex sodium solution for intravenous administration. The record is a regulatory action only and contains no clinical trial results, efficacy data, or safety outcomes. Readers should not infer clinical benefit or comparative advantage from this approval notice alone.

What was studied

Regulatory approval. Intervention: Sugammadex sodium solution for intravenous administration; two formulations: 200 mg base / 2 mL and 500 mg base / 5 mL..

Key findings

Safety

This is a regulatory action record and does not contain clinical trial results, efficacy data, or safety outcomes. No comparator product, efficacy endpoint, or adverse event data are reported.

Who this may help

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

Plain-language summary

FDA approval of sugammadex sodium for intravenous use; this is a regulatory action record that does not contain clinical trial outcome data.

Study design

As stated by the source record.

InterventionSugammadex sodium solution for intravenous administration; two formulations: 200 mg base / 2 mL and 500 mg base / 5 mL.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-28

Formulation 1SUGAMMADEX SODIUM 200 MG BASE / 2 ML (100 MG BASE / ML)

Formulation 2SUGAMMADEX SODIUM 500 MG BASE / 5 ML (100 MG BASE / ML)

Caveats

This is a regulatory action record and does not contain clinical trial results, efficacy data, or safety outcomes.
No comparator product, efficacy endpoint, or adverse event data are reported.
Approval status alone does not indicate magnitude of clinical benefit or comparative advantage over existing agents.
This is an ANDA (Abbreviated New Drug Application), suggesting a generic formulation; the record does not describe the reference product or equivalence studies.

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 record; no study design reported.

Directness

insufficient

No clinical outcome data provided in regulatory record.

Consistency

insufficient

No comparative data or consistency assessment reported.

Risk of bias

insufficient

Regulatory approval record does not report bias assessment.

Sample adequacy

insufficient

No sample size or population data reported in 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 ANDA214368. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX. Active ingredient: SUGAMMADEX. Sponsor: MSN. Submission type: ORIG (original application). Approval status date: 2026-07-28. Products: SUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML); SUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML).

Follow from this

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

SugammadexMSN