Is Lomitapide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Lomitapide, including Lojuxta (5 mg, Capsule, hard, SAR 91051.30); Lojuxta (10 mg, Capsule, hard, SAR 91051.30); Lojuxta (20 mg, Capsule, hard, SAR 91051.30); Lojuxta (2 mg, Capsule, hard, SAR 85910.00).

Is Lomitapide approved by the US FDA?

Drugs@FDA lists 2 application product lines for Lomitapide, including JUXTAPID (Prescription); JUXTAPID (Discontinued).

Is Lomitapide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lomitapide: Lojuxta.

Are there safety signals or safety updates for Lomitapide?

US FDA: 1 entry (latest 2026-02-25).

Active substance

Lomitapide

SFDA 4
US FDA 2
EMA 1
Health Canada 3
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Lojuxta	5 mg	Capsule, hard · Oral use	28 Bottle	SAR 91051.30	NCE · Prescription	Amryt Pharmaceuticals DAC	Valid
Lojuxta	10 mg	Capsule, hard · Oral use	28 Bottle	SAR 91051.30	NCE · Prescription	Amryt Pharmaceuticals DAC	Valid
Lojuxta	20 mg	Capsule, hard · Oral use	28 Bottle	SAR 91051.30	NCE · Prescription	Amryt Pharmaceuticals DAC	Valid
Lojuxta	2 mg	Capsule, hard · Oral use	28 Bottle	SAR 85910.00	NCE · Prescription	Amryt pharmaceuticals DAC	Valid

Indications — CHI Daman Drug Formulary

DYSLIPIDEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
JUXTAPID	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 2MG BASE	capsule · oral	CHIESI	Prescription	21 Dec 2012
JUXTAPID	EQ 40MG BASE; EQ 60MG BASE	capsule · oral	CHIESI	Discontinued	21 Dec 2012

EMA European Union — centrally authorised medicines

Lojuxta Chiesi Farmaceutici SpA · Authorised · authorised 31 Jul 2013 · ATC C10AX12

Therapeutic indication (EMA)

Lojuxta is indicated as an adjunct to a low?fat diet and other lipid?lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JUXTAPID	02420341	5 MG	CAPSULE · ORAL	CHIESI FARMACEUTICI S.P.A.
JUXTAPID	02420376	10 MG	CAPSULE · ORAL	CHIESI FARMACEUTICI S.P.A.
JUXTAPID	02420384	20 MG	CAPSULE · ORAL	CHIESI FARMACEUTICI S.P.A.

Safety signals and safety-related labeling changes

US FDA 25 Feb 2026 JUXTAPID — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for lomitapide →

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.