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As of Nov 14, 2026, ANDA 209301 (Lacosamide), held by Hetero Labs Ltd Iii, was first approved by FDA on May 31, 2022, with 2 approved supplements and 0 published complete response letters.
First approved: May 31, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Lacosamide oral solution is indicated for:
Treatment of partial-onset seizures in patients 1 month of age and older
Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older 1.1 Partial-Onset Seizures Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
