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 sugammadex sodium for intravenous administration on 28 July 2026 via original ANDA application ANDA215260, sponsored by Tamarang. This regulatory action does not disclose the supporting clinical trial results, efficacy data, or comparative evidence that informed the decision. Clinicians should consult the approved prescribing information and published evidence for clinical guidance on use.

What was studied

Regulatory approval.

Key findings

FDA approval granted 28 July 2026 for SUGAMMADEX SODIUM, SOLUTION, INTRAVENOUS formulations: 500 mg base/5 mL and 200 mg base/2 mL (both 100 mg base/mL) Original ANDA application (ANDA215260) from sponsor Tamarang

Safety

This regulatory record does not contain clinical trial results, efficacy data, safety data, or comparative outcome evidence. No information on indications, contraindications, dosing guidance, or adverse event profile is provided in this record.

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, not a clinical efficacy study, and does not report trial outcomes or comparative benefit.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-28

Formulation 1 strength500 mg base/5 mL (100 mg base/mL)

Formulation 2 strength200 mg base/2 mL (100 mg base/mL)

Caveats

This regulatory record does not contain clinical trial results, efficacy data, safety data, or comparative outcome evidence.
Approval status alone does not establish clinical superiority or optimal use cases; supporting evidence must be sought in published literature and prescribing information.
No information on indications, contraindications, dosing guidance, or adverse event profile is provided in this record.

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; no trial design reported.

Directness

insufficient

Regulatory approval record does not report clinical endpoints or outcomes.

Consistency

insufficient

No trial data or comparative results presented in this record.

Risk of bias

insufficient

Regulatory record does not contain study methodology or bias assessment.

Sample adequacy

insufficient

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

Source abstract

Drugs@FDA record for application ANDA215260. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX. Active ingredient: SUGAMMADEX. Sponsor: TAMARANG. 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.

SugammadexTamarang