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As of Nov 14, 2026, ANDA 214677 (Lacosamide), held by Fresenius Kabi USA, was first approved by FDA on May 3, 2022, with 1 approved supplement and 0 published complete response letters.
First approved: May 3, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Lacosamide Injection is indicated for:
Treatment of partial-onset seizures in patients 17 years of age and older 1.1 Partial-Onset Seizures Lacosamide Injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. Pediatric use information is approved for UCB, Inc.'s VIMPAT (lacosamide) injection. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
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
