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 an abbreviated new drug application (ANDA) for sugammadex sodium intravenous solution under two formulations (500 mg/5 mL and 200 mg/2 mL) submitted by Mankind Pharma on 28 July 2026. This is a regulatory action record and does not report clinical trial data, efficacy endpoints, or comparative clinical evidence.

What was studied

Regulatory approval. Intervention: Sugammadex sodium intravenous solution (500 mg/5 mL or 200 mg/2 mL formulations).

Key findings

Approval granted for SUGAMMADEX SODIUM SOLUTION, INTRAVENOUS, 500 mg/5 mL (100 mg/mL concentration) Approval granted for SUGAMMADEX SODIUM SOLUTION, INTRAVENOUS, 200 mg/2 mL (100 mg/mL concentration) Submission type: original application (ORIG); Sponsor: Mankind Pharma; Approval date: 2026-07-28

Safety

This regulatory record does not include clinical trial results, efficacy data, or safety endpoints. Population, sample size, study design, and adverse event profile are not documented here.

Who this may help

This regulatory approval enables availability of a generic sugammadex sodium formulation for reversal of neuromuscular blockade. Clinical professionals should consult prescribing information for indications, dosing, contraindications, and safety data, which are not contained in this approval record.

Plain-language summary

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

Study design

As stated by the source record.

InterventionSugammadex sodium intravenous solution (500 mg/5 mL or 200 mg/2 mL formulations)

Reported figures

Quoted from the source exactly as published.

Formulation 1 concentration500 mg/5 mL (100 mg/mL)

Formulation 2 concentration200 mg/2 mL (100 mg/mL)

Approval date2026-07-28

Clinical bottom line

Caveats

This regulatory record does not include clinical trial results, efficacy data, or safety endpoints.
No bioequivalence or comparative clinical data are reported in this record.
Population, sample size, study design, and adverse event profile are not documented here.
The record confirms formulation and concentration approval only; clinical guidance requires reference to full prescribing information.

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 study design reported.

Directness

insufficient

Record does not report clinical outcomes or therapeutic claims.

Consistency

insufficient

Single regulatory action; no comparative evidence presented.

Risk of bias

insufficient

Regulatory approval based on abbreviated new drug application standards.

Sample adequacy

insufficient

No clinical trial sample size or population data reported.

Source abstract

Drugs@FDA record for application ANDA214230. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX SODIUM. Active ingredient: SUGAMMADEX SODIUM. Sponsor: MANKIND PHARMA. 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 SodiumMankind Pharma