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

The FDA approved an Abbreviated New Drug Application (ANDA) for sugammadex sodium 200 mg/2 mL intravenous solution (HIKMA) on 28 July 2026. This is a regulatory action record documenting approval of a generic formulation; it does not contain clinical trial efficacy or safety data.

What was studied

Regulatory approval. Intervention: SUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, 200MG BASE/2ML.

Key findings

Approval status date: 2026-07-28 Formulation: SUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, 200MG BASE/2ML (100MG BASE/ML equivalence)

Safety

This record does not contain clinical trial results, efficacy data, or safety comparisons. No bioequivalence study results, population characteristics, or adverse event frequencies are reported in this approval record.

Who this may help

This regulatory record confirms FDA approval of a generic sugammadex product but does not provide clinical efficacy, safety, or comparative outcome data. Clinicians should refer to the established indication and safety profile of the reference brand and to the approved product labeling.

Plain-language summary

FDA approval of a generic sugammadex formulation; this is a regulatory action record without clinical trial data.

Study design

As stated by the source record.

InterventionSUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS, 200MG BASE/2ML

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-28

Concentration100 mg/mL

Total dose per vial200 mg base per 2 mL

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety comparisons.
No bioequivalence study results, population characteristics, or adverse event frequencies are reported in this approval record.
The record does not state indications, contraindications, or dosing recommendations; these derive from the reference product and labeling.
No information on manufacturing site, quality control testing, or comparative performance is provided.

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

Regulatory approval record; clinical outcomes not reported.

Consistency

insufficient

No comparative data or prior trials cited in this record.

Risk of bias

insufficient

Regulatory record does not disclose trial methods or bias assessment.

Sample adequacy

insufficient

No sample size or trial population data in approval record.

Source abstract

Drugs@FDA record for application ANDA218727. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX. Active ingredient: SUGAMMADEX. 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).

Follow from this

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

HikmaSugammadex