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Sugammadex Sodium · Regulatory approval
U.S. Food and Drug Administration · July 28, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA approval record for a generic intravenous formulation of sugammadex sodium (two concentrations: 500 mg/5 mL and 200 mg/2 mL at 100 mg/mL base). The record confirms regulatory authorization but does not disclose the clinical or bioequivalence evidence supporting approval.
Regulatory approval.
FDA approved sugammadex sodium intravenous solution at two strengths under ANDA 218814 on 28 July 2026 Formulation 1: 500 mg base per 5 mL (100 mg base/mL) Formulation 2: 200 mg base per 2 mL (100 mg base/mL)
This record does not contain clinical trial results, efficacy data, or safety outcomes. No information on pharmacokinetics, dosing guidance, or clinical indications is provided.
The source did not state who this applies to in practice.
FDA approval of a generic intravenous sugammadex sodium formulation; does not report clinical trial outcomes or comparative efficacy data.
Quoted from the source exactly as published.
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.
Drugs@FDA record for application ANDA218814. This is a regulatory action record, not a clinical study. Brand name: SUGAMMADEX SODIUM. Active ingredient: SUGAMMADEX SODIUM. Sponsor: STERISCIENCE. 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).
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