Regulatory PathRegulatory requirements compared

Active substance

Fosfomycin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Fomicyt40 mg/mlPowder for solution for infusion · Intravenous use10 BottleSAR 1356.65NCE · PrescriptionInfectopharm Arzneimittel und Consilium GmbHValid
Fomicyt40 mg/mlPowder for solution for infusion · Intravenous use10 BottleSAR 2713.35NCE · PrescriptionInfectopharm Arzneimittel und Consilium GmbHValid
Fomicyt40 mg/mlPowder for solution for infusion · Intravenous use10 BottleSAR 678.30NCE · PrescriptionInfectopharm Arzneimittel und Consilium GmbHValid
MONUROL3.0 gGranules · Oral use2 SachetSAR 64.50NCE · PrescriptionZAMBON SWITZERLAND LTDValid
MONUROL 3G SACHETS3 gGranules · Oral use1 SachetSAR 32.25NCE · PrescriptionZAMBON SWITZERLAND LTDValid
UNAIRA 3GM SACHET3 gGranules for oral solution · Oral use1 SachetSAR 29.90Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Indications — CHI Daman Drug Formulary

LOWER URINARY TRACT INFECTIONS; OSTEOMYELITIS; RECURRENT URINARY TRACT INFECTIONS (UTI)

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

ProductStrengthForm · routeApplicantStatusFirst approved
FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETfor solution · oralXIROMEDPrescription6 Oct 2020
FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETfor solution · oralALKEM LABS LTDPrescription21 Oct 2021
FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETfor solution · oralCIPLAPrescription26 Jan 2022
FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETfor solution · oralAMNEALPrescription25 Mar 2024
FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETfor solution · oralPRECISION DOSE INCPrescription3 Jun 2025
CONTEPOEQ 6GM BASE/VIALpowder · intravenousMEITHEALPrescription22 Oct 2025
FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETfor solution · oralAUROBINDO PHARMA LTDPrescription14 Nov 2025
FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETfor solution · oralAUCTAPrescription9 Apr 2026
FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETfor solution · oralNOVITIUM PHARMAPrescription12 Aug 2026
MONUROLEQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**for solution · oralZAMBON SPADiscontinued19 Dec 1996

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
IVOZFO024880864 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSVERITY PHARMACEUTICALS INC.
JAMP FOSFOMYCIN024738013 G / SACHETPOWDER FOR SOLUTION · ORALJAMP PHARMA CORPORATION
MONUROL022403353 G / SACHETPOWDER FOR SOLUTION · ORALKNIGHT THERAPEUTICS INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFOSFOMYCIN 3 GM SACHET$26.22036per EA30 Sep 2026
NHS Drug TariffFosfomycin 3g granules for oral solution sachets£5.101 sachet1 Oct 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)

  • 6.2.3. Reserve group antibiotics · complementary
    Carbapenem resistant Acinetobacter baumannii; Carbapenem-resistant Pseudomonas aeruginosa; Other carbapenem resistant Enterobacterales
    Parenteral > General injections > IV: 2 g in vial (as sodium) powder for injection; 4 g in vial (as sodium) powder for injection

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.