Is Lacosamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 41 valid registrations of Lacosamide, including LACOSAMIDE GENEPHARM (50 mg, Film-coated tablet, SAR 23.40); LACOSAMIDE GENEPHARM (100 mg, Film-coated tablet, SAR 170.50); LACOSAMIDE GENEPHARM (150 mg, Film-coated tablet, SAR 244.65); LACOSAMIDE GENEPHARM (200 mg, Film-coated tablet, SAR 326.15); LAZURE 100MG F.C.TABLET (100 mg, Film-coated tablet, SAR 226.20).

Is Lacosamide approved by the US FDA?

Drugs@FDA lists 48 application product lines for Lacosamide, including VIMPAT (Prescription); VIMPAT (Prescription); VIMPAT (Prescription); LACOSAMIDE (Prescription); LACOSAMIDE (Prescription).

Is Lacosamide authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Lacosamide: Vimpat, Lacosamide Accord, Lacosamide UCB, Lacosamide Adroiq.

Are there safety signals or safety updates for Lacosamide?

US FDA: 4 entries (latest 2024-06-07).

Active substance

Lacosamide

SFDA 41
US FDA 48
EMA 5
Health Canada 41
US price lines 12
NHS prices 7
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LACOSAMIDE GENEPHARM	50 mg	Film-coated tablet · Oral use	14 Blister	SAR 23.40	Generic · Prescription	GENEPHARM S.A.	Valid
LACOSAMIDE GENEPHARM	100 mg	Film-coated tablet · Oral use	56 Blister	SAR 170.50	Generic · Prescription	GENEPHARM S.A.	Valid
LACOSAMIDE GENEPHARM	150 mg	Film-coated tablet · Oral use	56 Blister	SAR 244.65	Generic · Prescription	GENEPHARM S.A.	Valid
LACOSAMIDE GENEPHARM	200 mg	Film-coated tablet · Oral use	56 Blister	SAR 326.15	Generic · Prescription	GENEPHARM S.A.	Valid
LAZURE 100MG F.C.TABLET	100 mg	Film-coated tablet · Oral use	60 Blister	SAR 226.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LAZURE 200MG F.C.TABLET	200 mg	Film-coated tablet · Oral use	60 Blister	SAR 453.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LAZURE 200MG SOLUTION FOR INFUSION	10 mg/ml	Solution for infusion · Intravenous use	5 Vial	SAR 420.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LAZURE 50MG F.C.TABLET	50 mg	Film-coated tablet · Oral use	60 Blister	SAR 117.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Lacosamide QO	10 mg/ml	Oral solution · Oral use	1 Bottle	SAR 75.70	Generic · Prescription	Qomel Co	Valid
Locovab	150 mg	Film-coated tablet · Oral use	56 Blister	SAR 270.75	Generic · Prescription	Med City Pharma	Valid
Locovab	100 mg	Film-coated tablet · Oral use	56 Blister	SAR 180.50	Generic · Prescription	Med City Pharma	Valid
Locovab	50 mg	Film-coated tablet · Oral use	56 Blister	SAR 93.80	Generic · Prescription	Med City Pharma	Valid
Locovab	200 mg	Film-coated tablet · Oral use	56 Blister	SAR 361.65	Generic · Prescription	Med City Pharma	Valid
Lomipat	200 mg	Tablet · Oral use	30 Blister	SAR 193.75	Generic · Prescription	Saudi Amarox	Valid
Lomipat	150 mg	Tablet · Oral use	30 Blister	SAR 145.05	Generic · Prescription	Saudi Amarox	Valid
Lomipat	100 mg	Tablet · Oral use	30 Blister	SAR 96.70	Generic · Prescription	Saudi Amarox	Valid
Lomipat	50 mg	Tablet · Oral use	30 Blister	SAR 50.25	Generic · Prescription	Saudi Amarox	Valid
Losapil	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 50.25	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Losapil	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 96.70	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Losapil	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 145.10	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Lusam	150 mg	Film-coated tablet · Oral use	56 Blister	SAR 270.80	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Lusam	100 mg	Film-coated tablet · Oral use	56 Blister	SAR 180.50	Generic · Prescription	SPIMACO	Valid
Lusam	50 mg	Film-coated tablet · Oral use	56 Blister	SAR 93.80	Generic · Prescription	SPIMACO	Valid
Lusam	10 mg/ml	Syrup · Oral use	1 Bottle	SAR 83.90	Generic · Prescription	SPIMACO	Valid
Lusam	200 mg	Film-coated tablet · Oral use	56 Blister	SAR 361.65	Generic · Prescription	SPIMACO	Valid

16 more — full table

Indications — CHI Daman Drug Formulary

FOCAL SEIZURES

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VIMPAT	50MG; 100MG; 150MG; 200MG	tablet · oral	UCB INC	Prescription	28 Oct 2008
VIMPAT	200MG/20ML (10MG/ML)	solution · intravenous	UCB INC	Prescription	28 Oct 2008
VIMPAT	10MG/ML	solution · oral	UCB INC	Prescription	20 Apr 2010
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	HETERO LABS LTD V	Prescription	17 Mar 2022
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	MSN LABS PVT LTD	Prescription	17 Mar 2022
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	ALEMBIC	Prescription	17 Mar 2022
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	17 Mar 2022
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	SUN PHARM	Prescription	17 Mar 2022
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	SCIEGEN PHARMS	Prescription	17 Mar 2022
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	REGCON HOLDINGS	Prescription	17 Mar 2022
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	ALKEM LABS LTD	Prescription	31 Mar 2022
LACOSAMIDE	200MG/20ML (10MG/ML)	solution · intravenous	REGCON HOLDINGS	Prescription	7 Apr 2022
LACOSAMIDE	200MG/20ML (10MG/ML)	solution · intravenous	FRESENIUS KABI USA	Prescription	3 May 2022
LACOSAMIDE	10MG/ML	solution · oral	ALKEM LABS LTD	Prescription	19 May 2022
LACOSAMIDE	10MG/ML	solution · oral	HETERO LABS LTD III	Prescription	31 May 2022
LACOSAMIDE	200MG/20ML (10MG/ML)	solution · intravenous	ZYDUS PHARMS	Prescription	29 Jun 2022
LACOSAMIDE	10MG/ML	solution · oral	NOVITIUM PHARMA	Prescription	26 Aug 2022
LACOSAMIDE	200MG/20ML (10MG/ML)	solution · intravenous	ASPIRO	Prescription	14 Sep 2022
LACOSAMIDE	200MG/20ML (10MG/ML)	solution · intravenous	GLAND	Prescription	19 Sep 2022
LACOSAMIDE	50MG; 100MG; 150MG; 200MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	5 Jan 2023
LACOSAMIDE	10MG/ML	solution · oral	KANCHAN HLTHCARE	Prescription	6 Feb 2023
LACOSAMIDE	200MG/20ML (10MG/ML)	solution · intravenous	MSN	Prescription	9 Feb 2023
MOTPOLY XR	100MG; 150MG; 200MG	capsule, extended release · oral	AUCTA	Prescription	4 May 2023
LACOSAMIDE	200MG/20ML (10MG/ML)	solution · intravenous	APOTEX	Prescription	13 Nov 2023
LACOSAMIDE	10MG/ML	solution · oral	MSN	Prescription	22 Dec 2023

23 more — full table

EMA European Union — centrally authorised medicines

Vimpat UCB Pharma SA · Authorised · authorised 29 Aug 2008 · ATC N03AX18

Therapeutic indication (EMA)

Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Lacosamide Accord Accord Healthcare S.L.U. · Authorised · authorised 18 Sep 2017 · ATC N03AX18

Therapeutic indication (EMA)

Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. Lacosamide Accord is indicated as adjunctive therapy • in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. • in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Lacosamide UCB UCB Pharma S.A. · Authorised · authorised 26 Aug 2019 · ATC N03AX18

Therapeutic indication (EMA)

Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Lacosamide Adroiq Extrovis EU Ltd · Authorised · authorised 31 May 2023 · ATC N03AX18

Therapeutic indication (EMA)

Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Lacosamide Adroiq is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Lacosamide Pain UCB Pharma UCB Pharma S.A. · Application withdrawn

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-LACOSAMIDE	02475332	50 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LACOSAMIDE	02475340	100 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LACOSAMIDE	02475359	150 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LACOSAMIDE	02475367	200 MG	TABLET · ORAL	AURO PHARMA INC
JAMP-LACOSAMIDE	02488388	50 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-LACOSAMIDE	02488396	100 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-LACOSAMIDE	02488418	150 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-LACOSAMIDE	02488426	200 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
LACOSAMIDE	02512874	50 MG	TABLET · ORAL	SANIS HEALTH INC
LACOSAMIDE	02512882	100 MG	TABLET · ORAL	SANIS HEALTH INC
LACOSAMIDE	02512890	150 MG	TABLET · ORAL	SANIS HEALTH INC
LACOSAMIDE	02512904	200 MG	TABLET · ORAL	SANIS HEALTH INC
MINT-LACOSAMIDE	02490544	50 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-LACOSAMIDE	02490552	100 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-LACOSAMIDE	02490560	150 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-LACOSAMIDE	02490579	200 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
PHARMA-LACOSAMIDE	02478196	50 MG	TABLET · ORAL	PHARMASCIENCE INC
PHARMA-LACOSAMIDE	02478218	100 MG	TABLET · ORAL	PHARMASCIENCE INC
PHARMA-LACOSAMIDE	02478226	150 MG	TABLET · ORAL	PHARMASCIENCE INC
PHARMA-LACOSAMIDE	02478234	200 MG	TABLET · ORAL	PHARMASCIENCE INC
RIVA-LACOSAMIDE	02565056	50 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
RIVA-LACOSAMIDE	02565064	100 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
RIVA-LACOSAMIDE	02565072	150 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
RIVA-LACOSAMIDE	02565080	200 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
SANDOZ LACOSAMIDE	02474670	50 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

16 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LACOSAMIDE 10 MG/ML SOLUTION	$0.08288	per ML	30 Sep 2026
US NADAC	LACOSAMIDE 100 MG TABLET	$0.17426	per EA	23 Sep 2026
US NADAC	LACOSAMIDE 100 MG/10 ML CUP	$0.08288	per ML	23 Sep 2026
US NADAC	LACOSAMIDE 150 MG TABLET	$0.22128	per EA	23 Sep 2026
US NADAC	LACOSAMIDE 200 MG TABLET	$0.24797	per EA	23 Sep 2026
US NADAC	LACOSAMIDE 200 MG/20 ML CUP	$0.08288	per ML	23 Sep 2026
US NADAC	LACOSAMIDE 50 MG TABLET	$0.11859	per EA	23 Sep 2026
US NADAC	VIMPAT 10 MG/ML SOLUTION	$2.29765	per ML	23 Sep 2026
US NADAC	VIMPAT 100 MG TABLET	$18.53662	per EA	23 Sep 2026
US NADAC	VIMPAT 150 MG TABLET	$19.64607	per EA	23 Sep 2026
US NADAC	VIMPAT 200 MG TABLET	$19.62683	per EA	23 Sep 2026
US NADAC	VIMPAT 50 MG TABLET	$11.82165	per EA	23 Sep 2026
NHS Drug Tariff	Lacosamide 100mg tablets	£2.40	56 tablet	1 Oct 2026
NHS Drug Tariff	Lacosamide 10mg/ml oral solution sugar free	£5.50	200 ml	1 Oct 2026
NHS Drug Tariff	Lacosamide 150mg tablets	£1.50	14 tablet	1 Oct 2026
NHS Drug Tariff	Lacosamide 150mg tablets	£5.99	56 tablet	1 Oct 2026
NHS Drug Tariff	Lacosamide 200mg tablets	£3.33	56 tablet	1 Oct 2026
NHS Drug Tariff	Lacosamide 200mg/20ml solution for infusion vials	£29.70	1 vial	1 Oct 2026
NHS Drug Tariff	Lacosamide 50mg tablets	£0.96	14 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 7 Jun 2024 MOTPOLY XR — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Apr 2023 VIMPAT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Apr 2023 VIMPAT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Apr 2023 VIMPAT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for lacosamide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.