Regulatory PathRegulatory requirements compared

Active substance

Natamycin

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
NATACYN5%suspension · ophthalmicHARROW EYEPrescription30 Oct 1978

WHO WHO Model List of Essential Medicines (2025)

  • 21.1. Ophthalmological preparations > Anti-infective agents · core
    Infectious keratitis
    Local > Ophthalmological > Suspension: 5% eye drops

Safety signals and safety-related labeling changes

  • US FDA 17 Nov 2025 NATACYN — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for natamycin →

Combinations containing Natamycin

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.