Sugammadex Sodium · Regulatory approval

FDA approval: Sugammadex Sodium

U.S. Food and Drug Administration · July 28, 2026

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AI Summary

The FDA approved a generic formulation of sugammadex sodium (HIKMA sponsor) as an intravenous solution in two strengths on 28 July 2026. This is a regulatory manufacturing and bioequivalence approval, not a clinical efficacy or safety trial, and does not report comparative clinical outcomes.

What was studied

Regulatory approval. Intervention: SUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, 200 mg/2 mL and 500 mg/5 mL formulations.

Key findings

Approval of SUGAMMADEX SODIUM 200 mg/2 mL (100 mg/mL) intravenous solution Approval of SUGAMMADEX SODIUM 500 mg/5 mL (100 mg/mL) intravenous solution Approval date: 28 July 2026; Application type: ANDA (abbreviated new drug application)

Safety

This record does not contain clinical trial results, efficacy data, or comparative safety information. Approval is based on abbreviated pathway (bioequivalence); no de novo efficacy or safety trials are reported.

Who this may help

Clinicians may now use this generic formulation of sugammadex sodium as an interchangeable alternative to branded versions for reversal of neuromuscular blockade; approval does not alter the clinical evidence base for the active ingredient itself.

Plain-language summary

FDA approval of a generic sugammadex sodium formulation; regulatory action confirms manufacturing and bioequivalence standards but does not report clinical trial efficacy data.

Study design

As stated by the source record.

InterventionSUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, 200 mg/2 mL and 500 mg/5 mL formulations

Reported figures

Quoted from the source exactly as published.

Approved strength 1SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approved strength 2SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval date2026-07-28

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or comparative safety information.
Approval is based on abbreviated pathway (bioequivalence); no de novo efficacy or safety trials are reported.
Population enrolled, sample size, and clinical outcomes are not described in this regulatory action.
Manufacturing and quality standards are confirmed but clinical dosing guidance is not restated in this approval notice.

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 approval record; no clinical trial design described.

Directness

insufficient

No clinical outcome data reported; approval based on bioequivalence pathway.

Consistency

insufficient

Single product approval; no comparative efficacy or safety data presented.

Risk of bias

insufficient

Regulatory action record does not include trial methodology or bias assessment.

Sample adequacy

insufficient

No clinical sample size or population data reported in approval notice.

Source abstract

Drugs@FDA record for application ANDA218728. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX SODIUM. Active ingredient: SUGAMMADEX SODIUM. Sponsor: HIKMA. 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.

Sugammadex SodiumHikma