Is Retapamulin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Retapamulin.

Is Retapamulin approved by the US FDA?

Drugs@FDA lists 1 application product line for Retapamulin, including ALTABAX (Discontinued).

Is Retapamulin authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Retapamulin.

Are there safety signals or safety updates for Retapamulin?

US FDA: 1 entry (latest 2019-09-10).

Active substance

Retapamulin

SFDA 1
US FDA 1
EMA 1
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
ALTARGO	1 %	Ointment · Topical	5 Tube	SAR 27.70	NCE · Prescription	GLAXO OPERATION LIMITED	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ALTABAX	1%	ointment · topical	ALMIRALL	Discontinued	12 Apr 2007

EMA European Union — centrally authorised medicines

Altargo Glaxo Group Ltd · Withdrawn · authorised 24 May 2007 · ATC D06AX13

Therapeutic indication (EMA)

Short term treatment of the following superficial skin infections: impetigo; infected small lacerations, abrasions or sutured wounds. See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Safety signals and safety-related labeling changes

US FDA 10 Sep 2019 ALTABAX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for retapamulin →

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.