MedPath

Moxifloxacin

Generic Name
Moxifloxacin
Brand Names
Avelox, Moxeza, Vigamox
Drug Type
Small Molecule
Chemical Formula
C21H24FN3O4
CAS Number
151096-09-2
Unique Ingredient Identifier
U188XYD42P

Overview

Moxifloxacin is a synthetic fluoroquinolone antibiotic agent. Bayer AG developed the drug (initially called BAY 12-8039) and it is marketed worldwide (as the hydrochloride) under the brand name Avelox (in some countries also Avalox) for oral treatment.

Indication

For the treatment of sinus and lung infections such as sinusitis, pneumonia, and secondary infections in chronic bronchitis. Also for the treatment of bacterial conjunctivitis (pinkeye).

Associated Conditions

  • Acute Exacerbation of Chronic Bronchitis (AECB)
  • Bacterial Conjunctivitis
  • Community Acquired Pneumonia (CAP)
  • Plague
  • Postoperative Infections
  • Postoperative Inflammatory Response
  • Sinusitis
  • Skin Infections
  • Ocular bacterial infections

Research Report

Published: Jul 11, 2025

A Comprehensive Monograph on Moxifloxacin: Pharmacology, Clinical Utility, and Safety Profile

Executive Summary and Introduction to Moxifloxacin

Overview

Moxifloxacin is a potent, fourth-generation synthetic fluoroquinolone antibiotic characterized by a broad spectrum of bactericidal activity against a wide range of Gram-positive, Gram-negative, atypical, and anaerobic pathogens.[1] Developed by Bayer AG under the initial research designation BAY 12-8039, it is a small molecule drug (DrugBank ID: DB00218; CAS Number: 151096-09-2) that has become a significant tool in the management of various bacterial infections.[1] It is marketed globally under several trade names, most notably Avelox® for systemic (oral and intravenous) formulations and Vigamox® or Moxeza® for ophthalmic use.[2]

Key Characteristics and Clinical Position

The clinical identity of moxifloxacin is defined by a profound duality. On one hand, it possesses several highly desirable attributes: enhanced potency against critical pathogens like multi-drug resistant Streptococcus pneumoniae (MDRSP), excellent activity against atypical respiratory pathogens, and a favorable pharmacokinetic profile that includes high oral bioavailability and a long half-life permitting once-daily dosing.[2] These characteristics led to its classification as a "respiratory quinolone" and secured its place in treating serious infections such as community-acquired pneumonia and drug-resistant tuberculosis.[4]

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Major Pharmaceuticals
0904-7407
ORAL
400 mg in 1 1
3/14/2024
AvPAK
50268-576
ORAL
400 mg in 1 1
5/16/2022
A-S Medication Solutions
50090-6248
OPHTHALMIC
5 mg in 1 mL
8/18/2020
Teva Pharmaceuticals USA, Inc.
0093-7387
ORAL
400 mg in 1 1
1/1/2022
RedPharm Drug, Inc.
67296-1679
ORAL
400 mg in 1 1
1/14/2021
Bryant Ranch Prepack
71335-2329
ORAL
400 mg in 1 1
6/25/2020
Novel Laboratories, Inc.
40032-034
ORAL
400 mg in 1 1
12/21/2019
Akorn
17478-519
OPHTHALMIC
5 mg in 1 mL
7/6/2017
Direct Rx
72189-334
OPHTHALMIC
5 mg in 1 mL
3/8/2022
DIRECT RX
72189-076
OPHTHALMIC
5 mg in 1 mL
3/3/2020

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
FLONOXIN FILM-COATED TABLET 400MG
SIN16347P
TABLET, FILM COATED
400MG
10/12/2021
MOLOXIN FILM-COATED TABLETS 400MG
SIN15579P
TABLET, FILM COATED
400.00mg
11/12/2018
AVELOX SOLUTION FOR INFUSION 400 mg/250 ml
SIN11971P
INJECTION
400 mg/250 ml
5/31/2002
MO-FLOREN OPHTHALMIC SOLUTION 0.5% USP
SIN14899P
SOLUTION, STERILE
5mg/ml
12/1/2015
AVELOX TABLET 400 mg
SIN11351P
TABLET, FILM COATED
400 mg
7/13/2000
MOXIFLOXACIN-TEVA F.C. TABLET 400 MG
SIN14900P
TABLET, FILM COATED
400 mg
12/1/2015
JOYLOXIN INJECTION 400MG/250ML
SIN15654P
INJECTION, SOLUTION
400MG
3/29/2019
FLOXSAFE 400 FILM COATED TABLET 400MG
SIN15361P
TABLET, FILM COATED
400 mg
11/14/2017
MOXETERO MOXIFLOXACIN FILM-COATED TABLETS 400 MG
SIN15769P
TABLET, FILM COATED
400.00 mg
8/6/2019
MOXIFLOXACIN KABI SOLUTION FOR INFUSION 400MG/250ML
SIN15310P
INFUSION, SOLUTION
400mg/250ml
7/31/2017

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
ZANAFLOX EYE DROPS 0.5% W/V
N/A
N/A
N/A
9/4/2024
MOXICIN EYE DROPS 0.5%
N/A
N/A
N/A
11/14/2011
VIGAMOX OPHTHALMIC SOLUTION 0.5%
N/A
N/A
N/A
4/1/2005

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
MOXIFLOXACINO RATIOPHARM 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Teva Pharma S.L.U.
77514
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
ABIMOX 5 MG/ML COLIRIO EN SOLUCION
Tiedra Farmaceutica S.L.
78338
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
MOXIFLOXACINO TEVAGEN 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Teva Pharma S.L.U.
76633
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.