Is Ambrisentan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Ambrisentan, including AMBRISENTAN GENEPHARM (5 mg, Film-coated tablet, SAR 3053.80); AMBRISENTAN GENEPHARM (10 mg, Film-coated tablet, SAR 3053.80); Ambracy (10 mg, Film-coated tablet, SAR 3288.75); Ambracy (5 mg, Film-coated tablet, SAR 3288.75); VOLIBRIS 10 mg film-coated tablet (10 mg, Film-coated tablet, SAR 3523.65).

Is Ambrisentan approved by the US FDA?

Drugs@FDA lists 10 application product lines for Ambrisentan, including LETAIRIS (Prescription); AMBRISENTAN (Prescription); AMBRISENTAN (Prescription); AMBRISENTAN (Prescription); AMBRISENTAN (Prescription).

Is Ambrisentan authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Ambrisentan: Volibris, Ambrisentan Viatris (previously Ambrisentan Mylan).

Are there safety signals or safety updates for Ambrisentan?

US FDA: 1 entry (latest 2025-04-04).

Active substance

Ambrisentan

SFDA 8
US FDA 10
EMA 3
Health Canada 4
US price lines 1
NHS prices 2
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
AMBRISENTAN GENEPHARM	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 3053.80	Generic · Prescription	GENEPHARM S.A.	Valid
AMBRISENTAN GENEPHARM	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 3053.80	Generic · Prescription	GENEPHARM S.A.	Valid
Ambracy	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 3288.75	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Ambracy	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 3288.75	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
VOLIBRIS 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 3523.65	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid
VOLIBRIS 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 3523.65	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid
VOLIBRIS 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 6007.55	NCE · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
VOLIBRIS 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 6007.55	NCE · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
LETAIRIS	5MG; 10MG	tablet · oral	GILEAD	Prescription	15 Jun 2007
AMBRISENTAN	5MG; 10MG	tablet · oral	WATSON LABS INC	Prescription	28 Mar 2019
AMBRISENTAN	5MG; 10MG	tablet · oral	MYLAN	Prescription	28 Mar 2019
AMBRISENTAN	5MG; 10MG	tablet · oral	ZYDUS PHARMS	Prescription	28 Mar 2019
AMBRISENTAN	5MG; 10MG	tablet · oral	SIGMAPHARM LABS LLC	Prescription	10 Apr 2019
AMBRISENTAN	5MG; 10MG	tablet · oral	CIPLA	Prescription	26 Apr 2019
AMBRISENTAN	5MG; 10MG	tablet · oral	APOTEX	Prescription	19 May 2022
AMBRISENTAN	5MG; 10MG	tablet · oral	AUROBINDO PHARMA	Prescription	21 Jul 2022
AMBRISENTAN	5MG; 10MG	tablet · oral	SUN PHARM	Discontinued	28 Mar 2019
AMBRISENTAN	5MG; 10MG	tablet · oral	PH HEALTH	Discontinued	10 Apr 2019

EMA European Union — centrally authorised medicines

Volibris GlaxoSmithKline Trading Services Limited · Authorised · authorised 21 Apr 2008 · ATC C02KX02

Therapeutic indication (EMA)

Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).

Ambrisentan Viatris (previously Ambrisentan Mylan) Viatris Limited · Authorised · authorised 20 Jun 2019 · ATC C02KX02

Therapeutic indication (EMA)

Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.

Ambrisentan Zentiva Zentiva k.s. · Application withdrawn · ATC C02KX02

Therapeutic indication (EMA)

Treatment of pulmonary arterial hypertension.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-AMBRISENTAN	02475375	5 MG	TABLET · ORAL	APOTEX INC
APO-AMBRISENTAN	02475383	10 MG	TABLET · ORAL	APOTEX INC
VOLIBRIS	02307065	5 MG	TABLET · ORAL	GLAXOSMITHKLINE INC
VOLIBRIS	02307073	10 MG	TABLET · ORAL	GLAXOSMITHKLINE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AMBRISENTAN 10 MG TABLET	$8.02453	per EA	23 Sep 2026
NHS Drug Tariff	Ambrisentan 10mg tablets	£1618.08	30 tablet	1 Oct 2026
NHS Drug Tariff	Ambrisentan 5mg tablets	£1618.08	30 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 4 Apr 2025 LETAIRIS — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ambrisentan →

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.