Lacosamide

Treats partial-onset seizures. ANDA 218014, held by Pharmazone. Lacosamide.

As of Nov 15, 2026, ANDA 218014 (Lacosamide), held by Pharmazone, was first approved by FDA on Apr 2, 2024, with 0 approved supplements and 0 published complete response letters.

First approved: Apr 2, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lacosamide tablets are indicated for:

Treatment of partial-onset seizures in patients 4 years 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 tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT (lacosamide) tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Apr 2, 2024	Original application	Approved	None posted

Products

4 strengths and forms


Lacosamide50MG · tablet;oral	Lacosamide	Rx
Lacosamide100MG · tablet;oral	Lacosamide	Rx
Lacosamide150MG · tablet;oral	Lacosamide	Rx
Lacosamide200MG · tablet;oral	Lacosamide	Rx

Identifiers

Application: ANDA 218014
Drugs@FDA: Overview at FDA
Company: Pharmazone

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