Is Moxifloxacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 31 valid registrations of Moxifloxacin, including AROX 0.5% EYE DROPS (0.5 %, Eye drops, SAR 25.25); AROX UD 0.5% EYE DROPS (5 %, Eye drops, SAR 33.35); AVALOX 400MG SOLUTION FOR I.V. INFUSION (400 mg, Solution for infusion, SAR 474.40); AVALOX 400MG TAB (400 mg, Film-coated tablet, SAR 61.90); AVORES 400 Film Coated Tablets (400 mg, Film-coated tablet, SAR 41.85).

Is Moxifloxacin approved by the US FDA?

Drugs@FDA lists 31 application product lines for Moxifloxacin, including AVELOX (Prescription); VIGAMOX (Prescription); MOXIFLOXACIN HYDROCHLORIDE (Prescription); MOXIFLOXACIN HYDROCHLORIDE (Prescription); MOXIFLOXACIN HYDROCHLORIDE (Prescription).

Is Moxifloxacin on the WHO Model List of Essential Medicines?

Yes — 6.2.5. Antituberculosis medicines (core list): Multi-drug resistant Mycobacterium tuberculosis; Tuberculosis.

Are there safety signals or safety updates for Moxifloxacin?

EMA PRAC: 5 entries; US FDA: 4 entries; MHRA: 1 entry (latest 2025-07-11).

Active substance

Moxifloxacin

SFDA 31
US FDA 31
Health Canada 13
US price lines 3
NHS prices 2
WHO EML 1
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AROX 0.5% EYE DROPS	0.5 %	Eye drops · Ophthalmic use	1 Dropper Container	SAR 25.25	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
AROX UD 0.5% EYE DROPS	5 %	Eye drops · Ocular use	30 Single Dose Container	SAR 33.35	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
AVALOX 400MG SOLUTION FOR I.V. INFUSION	400 mg	Solution for infusion · Intravenous use	5 Bottle	SAR 474.40	NCE · Prescription	BAYER AG	Valid
AVALOX 400MG TAB	400 mg	Film-coated tablet · Oral use	5 Blister	SAR 61.90	NCE · Prescription	BAYER AG	Valid
AVALOX 400MG TAB	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 80.40	NCE · Prescription	BAYER AG	Valid
AVORES 400 Film Coated Tablets	400 mg	Film-coated tablet · Oral use	5 Blister	SAR 41.85	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
AVORES 400 Film Coated Tablets	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 58.60	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
Avores	400 mg	Film-coated tablet · Oral use	336 Blister	SAR 2233.45	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
Elfonis 400 mg per 250 ml	1.6 mg/ml	Solution for infusion · Intravenous use	1 Bottle	SAR 76.95	Generic · Prescription	Hemofarm AD Vrsac	Valid
Eliflox	400 mg	Film-coated tablet · Oral use	5 Blister	SAR 41.85	Generic · Prescription	Elixir Pharmaceutical Company LLC	Valid
Eliflox	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 58.60	Generic · Prescription	Elixir Pharmaceutical Company LLC	Valid
FLOMOCIN 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	5 Blister	SAR 41.85	Generic · Prescription	LABORATORIOS CINFA SA	Valid
FLOMOCIN 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 58.60	Generic · Prescription	LABORATORIOS CINFA SA	Valid
FLOMOXIN 400 mg Solution for Infusion	1.6 mg/ml	Solution for infusion · Intravenous use	1 Bag	SAR 85.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
MAXIM 400MG FILM COATED TABLETS	400 mg	Tablet · Oral use	5 Blister	SAR 61.05	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
MAXIM 400MG FILM COATED TABLETS	400 mg	Tablet · Oral use	7 Blister	SAR 80.40	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
MOXICAN 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 58.60	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
MOXIFLOX 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	5 Blister	SAR 49.45	Generic · Prescription	DAMMAM PHARMA	Valid
MOXIFLOX 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 65.10	Generic · Prescription	DAMMAM PHARMA	Valid
MOXIQUIN 400MG TABLET	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 58.60	Generic · Prescription	OMAN PHARMACEUTICAL PRODUCTS	Valid
MOXIVE 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	5 Blister	SAR 54.95	Generic · Prescription	SPIMACO ADDWAEIH	Valid
MOXIVE 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 72.35	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Maxeva	400 mg	Film-coated tablet · Oral use	10 Blister	SAR 59.50	Generic · Prescription	Eva Pharma for Pharmaceuticals & Medical Appliances	Valid
Maxique 400 mg / 250 ml Solution For Intravenous Infusion	1.6 mg/ml	Solution for infusion · Intravenous use	1 Bag	SAR 81.00	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Moxiwar	400 mg	Film-coated tablet · Oral use	7 Blister	SAR 58.60	Generic · Prescription	Aurobindo Pharma Saudi Arabia Limited	Valid

6 more — full table

Indications — CHI Daman Drug Formulary

ANTIBIOTIC SURGICAL PROPHYLAXIS; MUCOPURULENT CONJUCTIVITIS - GONOCOCCAL INFECTION OF THE EYE - CHLAMYDIAL CONJUNCTIVITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
AVELOX	400MG	tablet · oral	BAYER PHARMS	Prescription	27 Apr 2001
VIGAMOX	EQ 0.5% BASE	solution/drops · ophthalmic	HARROW EYE	Prescription	15 Apr 2003
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	TEVA PHARMS USA	Prescription	18 Feb 2014
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	DR REDDYS	Prescription	4 Mar 2014
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	4 Mar 2014
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	LUPIN	Prescription	4 Sep 2014
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	REGCON HOLDINGS	Prescription	6 Mar 2015
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	solution · intravenous	FRESENIUS KABI USA	Prescription	3 Apr 2015
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	LUPIN	Prescription	28 May 2015
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	CROSSMEDIKA SA	Prescription	14 Jan 2016
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	CHARTWELL RX	Prescription	13 Feb 2017
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	solution · intravenous	MYLAN LABS LTD	Prescription	5 May 2017
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	APOTEX	Prescription	30 Jun 2017
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	MSN	Prescription	22 Sep 2017
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	EUGIA PHARMA	Prescription	4 Oct 2017
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	SUNSHINE	Prescription	28 Sep 2018
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	ALEMBIC	Prescription	13 Feb 2019
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	GLAND	Prescription	30 Mar 2020
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	UPSHER SMITH LABS	Prescription	10 Feb 2021
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	HETERO LABS LTD V	Prescription	2 Mar 2023
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	SOMERSET THERAPS LLC	Prescription	14 Nov 2024
MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	MANKIND PHARMA	Prescription	27 Jan 2025
MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	MACLEODS PHARMS	Prescription	2 Mar 2026
AVELOX	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	BAYER HLTHCARE	Discontinued	10 Dec 1999
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · intravenous	BAYER HLTHCARE	Discontinued	30 Nov 2001

6 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-MOXIFLOXACIN	02406373	0.5 % / W/V	SOLUTION · OPHTHALMIC	APOTEX INC
AURO-MOXIFLOXACIN	02432242	400 MG	TABLET · ORAL	AURO PHARMA INC
JAMP-MOXIFLOXACIN	02443929	400 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-MOXIFLOXACIN	02472791	400 MG	TABLET · ORAL	MANTRA PHARMA INC
MOXIFLOXACIN	02462974	400 MG	TABLET · ORAL	PRO DOC LIMITEE
MOXIFLOXACIN	02520710	400 MG	TABLET · ORAL	SANIS HEALTH INC
MOXIFLOXACIN	02529076	0.5 % / W/V	SOLUTION · OPHTHALMIC	SANIS HEALTH INC
MOXIFLOXACIN INJECTION	02433087	400 MG / 250 ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
PMS-MOXIFLOXACIN	02432218	0.5 %	SOLUTION · OPHTHALMIC	PHARMASCIENCE INC
SANDOZ MOXIFLOXACIN	02383381	400 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ MOXIFLOXACIN	02411520	0.5 %	SOLUTION · OPHTHALMIC	SANDOZ CANADA INCORPORATED
TEVA-MOXIFLOXACIN	02375702	400 MG	TABLET · ORAL	TEVA CANADA LIMITED
VIGAMOX	02252260	0.5 %	SOLUTION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MOXIFLOXACIN 0.5% EYE DROPS	$1.59631	per ML	23 Sep 2026
US NADAC	MOXIFLOXACIN HCL 400 MG TABLET	$1.33723	per EA	23 Sep 2026
US NADAC	VIGAMOX 0.5% EYE DROPS	$31.808	per ML	17 Jun 2026
NHS Drug Tariff	Moxifloxacin 0.5% eye drops	£9.80	5 ml	1 Oct 2026
NHS Drug Tariff	Moxifloxacin 400mg tablets	£10.99	5 tablet	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.

WHO WHO Model List of Essential Medicines (2025)

6.2.5. Antituberculosis medicines · core
Multi-drug resistant Mycobacterium tuberculosis; Tuberculosis
Oral > Solid > dispersible tablet: 100 mg (EMLc) | Oral > Solid > tablet: 400 mg

Safety signals and safety-related labeling changes

US FDA 11 Jul 2025 AVELOX — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 2 Sep 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No
US FDA 11 Aug 2021 MOXEZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations
EMA PRAC 9 Apr 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No
EMA PRAC 3 Sep 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: Yes
EMA PRAC 14 May 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: No
US FDA 11 May 2020 VIGAMOX — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Mar 2020 MOXIFLOXACIN HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 16 Jan 2020 PRAC signal: Heart valve regurgitation
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Moxifloxacin: increased risk of life-threatening liver reactions and other serious risks
Use in pelvic inflammatory disease only when other antibacterials are inappropriate or ineffective.

All safety entries for moxifloxacin →

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.