Is Loteprednol etabonate + Tobramycin 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 Loteprednol etabonate + Tobramycin, including Lotinil (0.5,0.3 %,%, Eye drops, solution, SAR 64.00).

Is Loteprednol etabonate + Tobramycin approved by the US FDA?

Drugs@FDA lists 2 application product lines for Loteprednol etabonate + Tobramycin, including ZYLET (Prescription); LOTEPREDNOL ETABONATE AND TOBRAMYCIN (Prescription).

Active substances

Loteprednol etabonate + Tobramycin

SFDA 1
US FDA 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Lotinil	0.5,0.3 %,%	Eye drops, solution · Ophthalmic use	1 Bottle	SAR 64.00	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ZYLET	0.5%;0.3%	suspension/drops · ophthalmic	BAUSCH AND LOMB	Prescription	14 Dec 2004
LOTEPREDNOL ETABONATE AND TOBRAMYCIN	0.5%;0.3%	suspension/drops · ophthalmic	ALEMBIC	Prescription	10 Dec 2025

Components

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.