Sugammadex Sodium · Regulatory approval

FDA approval: Sugammadex Sodium

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

The FDA approved a generic intravenous sugammadex sodium formulation (500 mg/5 mL and 200 mg/2 mL, 100 mg/mL concentration) as an original ANDA application on 28 July 2026. This regulatory action confirms bioequivalence to the reference product but does not report clinical efficacy, safety outcomes, or comparative trial results.

What was studied

Regulatory approval.

Key findings

Two formulations approved: SUGAMMADEX SODIUM 500MG BASE/5ML and 200MG BASE/2ML, both at 100MG BASE/ML concentration Approval date: 2026-07-28 Sponsor: TEVA PHARMS USA INC

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes Sponsor: TEVA PHARMS USA INC

Who this may help

This approval makes a generic intravenous sugammadex formulation available; it does not report new clinical efficacy or safety data and should be interpreted as a regulatory confirmation of bioequivalence to the brand-name product.

Plain-language summary

FDA approval of a generic intravenous sugammadex formulation; regulatory action does not report efficacy or comparative clinical trial data.

Reported figures

Quoted from the source exactly as published.

Formulation 1 strength500MG BASE/5ML (EQ 100MG BASE/ML)

Formulation 2 strength200MG BASE/2ML (EQ 100MG BASE/ML)

Approval date2026-07-28

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes
No comparative effectiveness study or bioequivalence study results are presented in this regulatory action
The record does not specify dose recommendations, indications, or clinical populations studied
Bioequivalence data underpinning the approval are not disclosed in this summary

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

Record documents approval only; no clinical outcomes reported.

Consistency

insufficient

No comparative data or trial results in this regulatory record.

Risk of bias

insufficient

Regulatory record does not contain trial methodology or bias assessment.

Sample adequacy

insufficient

No clinical trial data or sample size reported in this approval record.

Source abstract

Drugs@FDA record for application ANDA214126. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX SODIUM. Active ingredient: SUGAMMADEX SODIUM. Sponsor: TEVA PHARMS USA INC. Submission type: ORIG (original application). Approval status date: 2026-07-28. Products: SUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML); SUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, SUGAMMADEX SODIUM EQ 200MG BASE/2ML (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.

Sugammadex SodiumTeva Pharms USA