Is Abacavir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Abacavir, including ZIAGEN 300MG TAB (300 mg, Film-coated tablet, SAR 944.75).

Is Abacavir approved by the US FDA?

Drugs@FDA lists 10 application product lines for Abacavir, including ZIAGEN (Prescription); ABACAVIR SULFATE (Prescription); ABACAVIR SULFATE (Prescription); ABACAVIR SULFATE (Prescription); ABACAVIR SULFATE (Prescription).

Is Abacavir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Abacavir: Ziagen.

Is Abacavir on the WHO Model List of Essential Medicines?

Yes — 6.4.2.1. Antiretrovirals > Nucleoside/Nucleotide reverse transcriptase inhibitors (core list): Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

Are there safety signals or safety updates for Abacavir?

EMA PRAC: 2 entries; US FDA: 6 entries; MHRA: 1 entry (latest 2025-10-28).

Active substance

Abacavir

SFDA 2
US FDA 10
EMA 1
Health Canada 3
US price lines 1
WHO EML 1
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ZIAGEN 300MG TAB	300 mg	Film-coated tablet · Oral use	60 Blister	SAR 944.75	NCE · Prescription	Glaxo Saudi Arabia Ltd	Valid
ZIAGEN 20MG\ML ORAL SOLUTION	20 mg/ml	Oral solution · Oral use	1 Bottle	SAR 242.85	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HUMAN IMMUNODEFICIENCY VIRUS

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

Product	Strength	Form · route	Applicant	Status	First approved
ZIAGEN	EQ 20MG BASE/ML	solution · oral	VIIV HLTHCARE	Prescription	17 Dec 1998
ABACAVIR SULFATE	EQ 300MG BASE	tablet · oral	MYLAN PHARMS INC	Prescription	18 Jun 2012
ABACAVIR SULFATE	EQ 300MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	17 Dec 2012
ABACAVIR SULFATE	EQ 300MG BASE	tablet · oral	HETERO LABS LTD III	Prescription	13 Sep 2013
ABACAVIR SULFATE	EQ 20MG BASE/ML	solution · oral	HETERO LABS LTD III	Prescription	26 Sep 2016
ABACAVIR SULFATE	EQ 300MG BASE	tablet · oral	CHARTWELL RX	Prescription	28 Oct 2016
ABACAVIR SULFATE	EQ 300MG BASE	tablet · oral	CIPLA	Prescription	21 Nov 2017
ABACAVIR SULFATE	EQ 20MG BASE/ML	solution · oral	AUROBINDO PHARMA LTD	Prescription	14 Mar 2018
ZIAGEN	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	VIIV HLTHCARE	Discontinued	17 Dec 1998
ABACAVIR SULFATE	EQ 300MG BASE	tablet · oral	APOTEX INC	Discontinued	17 Dec 2012

EMA European Union — centrally authorised medicines

Ziagen ViiV Healthcare B.V. · Authorised · authorised 8 Jul 1999 · ATC J05AF06

Therapeutic indication (EMA)

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-ABACAVIR	02396769	300 MG	TABLET · ORAL	APOTEX INC
MINT-ABACAVIR	02480956	300 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
ZIAGEN	02240358	20 MG / ML	SOLUTION · ORAL	VIIV HEALTHCARE ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ABACAVIR 300 MG TABLET	$0.54555	per EA	23 Sep 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.

WHO WHO Model List of Essential Medicines (2025)

6.4.2.1. Antiretrovirals > Nucleoside/Nucleotide reverse transcriptase inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Solid: 300 mg tablet (as sulfate)

Safety signals and safety-related labeling changes

US FDA 28 Oct 2025 TRIUMEQ — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Oct 2025 TRIUMEQ PD — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Dec 2021 EPZICOM — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Feb 2021 TRIZIVIR — 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
US FDA 24 Nov 2020 ZIAGEN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Nov 2020 ZIAGEN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Abacavir: risk of myocardial infarction—update from epidemiological studies
Abacavir should be used in line with current treatment guidelines and with caution in patients with high cardiovascular risk factors.

All safety entries for abacavir →

Combinations containing Abacavir

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.