Overview
Delafloxacin is a fluoroquinolone antibiotic which has been used in trials studying the treatment and basic science of Gonorrhea, Hepatic Impairment, Bacterial Skin Diseases, Skin Structure Infections, and Community Acquired Pneumonia, among others. It was approved in June 2017 under the trade name Baxdela for use in the treatment of acute bacterial skin and skin structure infections.
Indication
Delafloxacin is indicated for the treatment of acute bacterial skin and skin structure infections caused by the Gram-positive organisms Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis as well as the Gram-negative organisms Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa .
Associated Conditions
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
- Community-Acquired Bacterial Pneumonia (CABP)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/25 | Phase 1 | Terminated | |||
2019/08/01 | Phase 3 | Terminated | Menarini Group | ||
2018/05/23 | Phase 1 | Completed | |||
2016/02/10 | Phase 3 | Completed | |||
2015/07/22 | Phase 1 | Completed | |||
2014/09/19 | Phase 1 | Completed | |||
2013/12/19 | Phase 3 | Terminated | |||
2013/11/15 | Phase 3 | Completed | |||
2013/03/15 | Phase 3 | Completed | |||
2011/01/26 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Melinta Therapeutics, LLC | 70842-102 | INTRAVENOUS | 300 mg in 10.5 mL | 7/2/2021 | |
| Melinta Therapeutics, LLC | 70842-101 | ORAL | 450 mg in 1 1 | 7/2/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/16/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| QUOFENIX POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 300MG | N/A | N/A | N/A | 12/15/2024 | |
| QUOFENIX TABLETS 450MG | N/A | N/A | N/A | 12/15/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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