Is Fidaxomicin 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 Fidaxomicin, including DIFICLIR 200 mg Film Coated Tablet (200 mg, Film-coated tablet, SAR 5677.50).

Is Fidaxomicin approved by the US FDA?

Drugs@FDA lists 7 application product lines for Fidaxomicin, including DIFICID (Prescription); DIFICID (Prescription); FIDAXOMICIN (Prescription); FIDAXOMICIN (Prescription); FIDAXOMICIN (Prescription).

Is Fidaxomicin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fidaxomicin: Dificlir.

Are there safety signals or safety updates for Fidaxomicin?

US FDA: 1 entry (latest 2020-01-24).

Active substance

Fidaxomicin

SFDA 1
US FDA 7
EMA 1
Health Canada 1
US price lines 2
NHS prices 2
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
DIFICLIR 200 mg Film Coated Tablet	200 mg	Film-coated tablet · Oral use	20 Blister	SAR 5677.50	NCE · Prescription	Tillotts Pharma GmbH	Valid

Indications — CHI Daman Drug Formulary

BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - CLOSTRIDIUM DIFFICILE INFECTIONS; DIARRHEA

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

Product	Strength	Form · route	Applicant	Status	First approved
DIFICID	200MG	tablet · oral	CUBIST PHARMS LLC	Prescription	27 May 2011
DIFICID	40MG/ML	for suspension · oral	CUBIST PHARMS LLC	Prescription	24 Jan 2020
FIDAXOMICIN	200MG	tablet · oral	ACTAVIS LABS FL	Prescription	16 Jan 2024
FIDAXOMICIN	200MG	tablet · oral	TORRENT	Prescription	27 Jan 2026
FIDAXOMICIN	200MG	tablet · oral	APOTEX	Prescription	2 Feb 2026
FIDAXOMICIN	200MG	tablet · oral	SANDOZ	Prescription	13 Aug 2026
FIDAXOMICIN	200MG	tablet · oral	HIKMA PHARMS	Prescription

EMA European Union — centrally authorised medicines

Dificlir Tillotts Pharma GmbH · Authorised · authorised 5 Dec 2011 · ATC A07AA12

Therapeutic indication (EMA)

Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. Dificlir granules for oral suspension is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age. Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DIFICID	02387174	200 MG	TABLET · ORAL	MERCK CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DIFICID 200 MG TABLET	$248.37854	per EA	23 Sep 2026
US NADAC	FIDAXOMICIN 200 MG TABLET	$90.5046	per EA	23 Sep 2026
NHS Drug Tariff	Fidaxomicin 200mg tablets	£1350.00	20 tablet	1 Oct 2026
NHS Drug Tariff	Fidaxomicin 40mg/ml oral suspension sugar free	£1350.00	110 ml	1 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.

Safety signals and safety-related labeling changes

US FDA 24 Jan 2020 DIFICID — 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 fidaxomicin →

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.