Drug or technology

Sugammadex Sodium

3 developments in the corpus

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JUL 28, 2026 · REGULATORY APPROVAL

FDA approval: Sugammadex Sodium

U.S. Food and Drug Administration

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

Regulatory UpdateSugammadex Sodium Steriscience

Reported

Approval date2026-07-28

Application numberANDA218814

Formulation 1 strength500 mg base/5 mL

JUL 28, 2026 · REGULATORY APPROVAL

FDA approval: Sugammadex Sodium

U.S. Food and Drug Administration

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

Regulatory UpdateSugammadex Sodium Mankind Pharma

Reported

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

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

Approval date2026-07-28

JUL 28, 2026 · REGULATORY APPROVAL

FDA approval: Sugammadex Sodium

U.S. Food and Drug Administration

FDA approval of a generic sugammadex sodium formulation; regulatory action confirms manufacturing and bioequivalence standards but does not report clinical trial efficacy data.

Insufficient InformationSugammadex Sodium Hikma

Reported

Approved strength 1SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100…

Approved strength 2SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100…

Approval date2026-07-28