FDA approval of an intravenous levetiracetam formulation; establishes regulatory authorization but does not report clinical trial data or efficacy outcomes.
Reported
Approval date2026-08-06
Formulation strength500 mg/5 mL (100 mg/mL)
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FDA approval of an intravenous levetiracetam formulation; establishes regulatory authorization but does not report clinical trial data or efficacy outcomes.
JUN 8, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
This is an FDA supplemental approval for levetiracetam labeling; it documents a regulatory action, not a clinical trial, and does not report efficacy or safety data.
MAY 8, 2026 · REGULATORY APPROVAL
U.S. Food and Drug Administration
FDA approval of a generic intravenous levetiracetam formulation; regulatory action, not a clinical trial or efficacy study.
APR 21, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
This is an FDA supplemental approval for a labeling change to levetiracetam oral solution; it documents a regulatory action, not clinical trial evidence.
APR 9, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval for labeling changes to levetiracetam extended-release formulations; does not report clinical trial outcomes or comparative efficacy.
APR 8, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval for labeling change to an established generic antiepileptic; does not contain clinical trial data or efficacy evidence.