Is Ozenoxacin 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 Ozenoxacin, including OZANEX (1 %, Cream, SAR 62.70).

Is Ozenoxacin approved by the US FDA?

Drugs@FDA lists 1 application product line for Ozenoxacin, including XEPI (Discontinued).

Active substance

Ozenoxacin

SFDA 1
US FDA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OZANEX	1 %	Cream · Cutaneous use	1 Tube	SAR 62.70	NCE · Prescription	FERRER INTERNATIONAL - S.A	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
XEPI	1%	cream · topical	LNHC	Discontinued	11 Dec 2017

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.