AVELOX (moxifloxacin hydrochloride)
AVELOX is indicated for the treatment of Community Acquired Pneumonia; Skin and Skin Structure Infections; Complicated Intra-Abdominal Infections; Plague; Acute Bacterial Sinusitis; Acute Bacterial Exacerbation of Chronic Bronchitis.
How AVELOX Works
Moxifloxacin is a fluoroquinolone that exerts bactericidal activity by inhibiting the bacterial type II topoisomerases, DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
Details
- Status
- Prescription
- First Approved
- 1999-12-10
- Routes
- Oral, ORAL
- Dosage Forms
- Tablet, TABLET
AVELOX Approval History
What AVELOX Treats
6 indicationsAVELOX is approved for 6 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Community Acquired Pneumonia
- Skin and Skin Structure Infections
- Complicated Intra-Abdominal Infections
- Plague
- Acute Bacterial Sinusitis
- Acute Bacterial Exacerbation of Chronic Bronchitis
AVELOX Boxed Warning
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1) ] , including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] Peripheral neuropathy [see Warnings and Precaution...
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1) ] , including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] Peripheral neuropathy [see Warnings and Precautions (5.3) ] Central nervous system effects [see Warnings and Precautions (5.4) ] Discontinue moxifloxacin hydrochloride immediately and avoid the use of fluoroquinolones, including moxifloxacin hydrochloride, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1) ]. Fluoroquinolones, including moxifloxacin hydrochloride, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin hydrochloride in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5) ]. Because fluoroquinolones, including moxifloxacin hydrochloride, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.14) ] , reserve moxifloxacin hydrochloride for use in patients who have no alternative treatment options for the following indications: Acute bacterial sinusitis [see Indications and Usage (1.6) ] Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.7) ] WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1) including: Tendinitis and tendon rupture (5.2) Peripheral Neuropathy (5.3) Central nerv
AVELOX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06795204 results posted | HSK3486-112 | Ph 1 | completed | Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT) |
| NCT05400369 | DSCN-GRV AECOPD-CSIS-001 | Ph 4 | completed | A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease |
| NCT04821063 results posted | ITF/2357/54 2020-003105-63 | Ph 1 | completed | Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval |
| NCT01910415 | VX12-809-008 | Ph 1 | completed | Phase 1, QT/QTC Interval Study in Healthy Subjects |
| NCT01594255 | CAEB071A2115 | Ph 1 | completed | CAEB071 Thorough QTc Study in Healthy Volunteers |
| NCT00758199 | 2008-0036 | Ph 4 | completed | Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery |
| NCT00824070 results posted | 575 | Ph 1 | completed | Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AVELOX FDA Label Details
Indications & Usage
FDA Label (PDF)AVELOX is indicated for the treatment of Community Acquired Pneumonia; Skin and Skin Structure Infections; Complicated Intra-Abdominal Infections; Plague; Acute Bacterial Sinusitis; Acute Bacterial Exacerbation of Chronic Bronchitis.
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious advers...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.