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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/15 | Phase 1 | Not yet recruiting | |||
2025/06/11 | Not Applicable | Recruiting | |||
2025/04/08 | Phase 2 | Not yet recruiting | Shandong University | ||
2025/04/01 | Phase 3 | Not yet recruiting | Shenzhen Third People's Hospital | ||
2025/03/25 | Phase 1 | Recruiting | |||
2025/03/03 | Phase 1 | Active, not recruiting | |||
2025/02/20 | Phase 1 | Completed | |||
2025/01/27 | Phase 1 | Completed | |||
2025/01/20 | Phase 4 | Completed | Inas Abd | ||
2024/12/24 | Phase 1 | Recruiting |
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 |
|---|---|---|---|---|---|
| Moxifloxacin Hydrochloride Injection | 国药准字H20193201 | 化学药品 | 注射剂 | 7/4/2019 | |
| Moxifloxacin Hydrochloride Injection | 国药准字H20140125 | 化学药品 | 注射剂 | 6/14/2024 | |
| Moxifloxacin Hydrochloride Injection | 国药准字H20213879 | 化学药品 | 注射剂 | 11/24/2021 | |
| Moxifloxacin Hydrochloride Injection | 国药准字H20193431 | 化学药品 | 注射剂 | 8/23/2024 | |
| Moxifloxacin Hydrochloride Injection | 国药准字H20130039 | 化学药品 | 注射剂 | 10/19/2022 | |
| Moxifloxacin Hydrochloride Injection | 国药准字H20193203 | 化学药品 | 注射剂 | 7/4/2019 | |
| Moxifloxacin Hydrochloride and Sodium Chloride Injection | 国药准字H20243417 | 化学药品 | 注射剂 | 3/29/2024 | |
| Moxifloxacin Hydrochloride and Sodium Chloride Injection | 国药准字H20249449 | 化学药品 | 注射剂 | 11/22/2024 | |
| Moxifloxacin Hydrochloride and Sodium Chloride Injection | 国药准字HJ20140424 | 化学药品 | 注射剂 | 9/22/2023 | |
| Moxifloxacin Hydrochloride and Sodium Chloride Injection | 国药准字H20234493 | 化学药品 | 注射剂 | 11/21/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AVELOX IV 400 moxifloxacin 400 mg/250 mL (as hydrochloride) intravenous infusion solution bag | 78977 | Medicine | A | 1/31/2002 | |
| AVELOX IV 400 moxifloxacin 400 mg/250 mL (as hydrochloride) intravenous infusion solution bottle | 81598 | Medicine | A | 1/31/2002 | |
| AVELOX moxifloxacin 400 mg (as hydrochloride) tablet blister pack | 75766 | Medicine | A | 12/21/2000 | |
| MOXIFLOXACIN KABI moxifloxacin (as hydrochloride) 400mg/250mL intravenous infusion injection bag | 241252 | Medicine | A | 5/9/2016 | |
| MOXIFLOXACIN KABI moxifloxacin (as hydrochloride) 400mg/250mL intravenous infusion injection bottle | 241253 | Medicine | A | 5/9/2016 | |
| MOXIFLOXACIN-BAXTER moxifloxacin (as hydrochloride) 400 mg/250 mL solution for intravenous infusion bottle | 260842 | Medicine | A | 8/30/2016 | |
| MOXIFLOXACIN-AFT moxifloxacin (as hydrochloride) 400 mg / 250 mL intravenous infusion injection bottle | 405619 | Medicine | A | 4/16/2025 |