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 is an FDA regulatory approval (ANDA 213915) of a generic sugammadex sodium formulation by Mylan, approved on 28 July 2026. The record is a regulatory action only and does not contain clinical trial results, efficacy data, or comparative outcomes.

What was studied

Regulatory approval.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, safety analyses, or comparative evidence.

Who this may help

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

Plain-language summary

FDA approval of a generic sugammadex formulation; regulatory action does not provide clinical trial evidence of efficacy or comparative benefit.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-28

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

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

Caveats

This record does not contain clinical trial results, efficacy data, safety analyses, or comparative evidence.
No patient population, sample size, or outcome measures are reported.
Approval of a generic formulation indicates bioequivalence to the reference product but does not provide clinical efficacy or comparative effectiveness data.

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 record, not a clinical study.

Directness

insufficient

No clinical outcomes or comparisons reported in regulatory record.

Consistency

insufficient

No comparative data provided in this approval record.

Risk of bias

insufficient

Regulatory approval does not detail trial design or bias assessment.

Sample adequacy

insufficient

No sample size or patient population data 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 ANDA213915. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX. Active ingredient: SUGAMMADEX. Sponsor: MYLAN. 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.

SugammadexMylan