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 a generic sugammadex sodium solution (Lupin, ANDA214338) on 28 July 2026. This regulatory action confirms that the applicant met the agency's standards for bioequivalence or other approvability criteria for the generic formulation. The record does not disclose clinical trial data, efficacy outcomes, or comparative safety.

What was studied

Regulatory approval.

Key findings

Approval granted for sugammadex sodium 200 mg base/2 mL (100 mg base/mL) intravenous solution Approval granted for sugammadex sodium 500 mg base/5 mL (100 mg base/mL) intravenous solution

Safety

This record is a regulatory action, not a clinical trial, and does not report efficacy, safety outcomes, or comparative data.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of a generic sugammadex formulation; regulatory action does not itself establish clinical efficacy or comparative benefit.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-28

Formulation 1 strength200 mg base/2 mL (100 mg base/mL)

Formulation 2 strength500 mg base/5 mL (100 mg base/mL)

Caveats

This record is a regulatory action, not a clinical trial, and does not report efficacy, safety outcomes, or comparative data.
Bioequivalence or other bridging data are not disclosed in this regulatory record.
Clinical evidence supporting the approved indication is not included.

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 clinical study design reported.

Directness

insufficient

Record documents approval status, not clinical outcomes or evidence.

Consistency

insufficient

No comparative efficacy or safety data presented in record.

Risk of bias

insufficient

Not applicable to regulatory approval action record.

Sample adequacy

insufficient

No study population or sample size disclosed.

Source abstract

Drugs@FDA record for application ANDA214338. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX. Active ingredient: SUGAMMADEX. Sponsor: LUPIN. 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.

LupinSugammadex