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AboutPricing
Drug ReportsDelafloxacin meglumine
Delafloxacin meglumine
Baxdela, Quofenix (delafloxacin meglumine) is a small molecule pharmaceutical. Delafloxacin meglumine was first approved as Baxdela on 2017-06-19. It is used to treat bacterial infections, bacterial skin diseases, escherichia coli infections, klebsiella infections, and staphylococcal infections amongst others in the USA. It has been approved in Europe to treat community-acquired infections.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
baxdelaNew Drug Application2025-08-01
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
DELAFLOXACIN MEGLUMINE, BAXDELA, MELINTA
2027-06-19GAIN
2022-06-19NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Delafloxacin Meglumine, Baxdela, Melinta
94935822033-02-27DP
77281432031-06-19DP
RE466172029-12-28DP
88719382029-09-23DP
76357732029-03-13DP
84100772029-03-13DP
92000882029-03-13DP
97508222029-03-13DP
82528132026-10-02DPU-2028
82738922026-08-06DP
86480932025-10-07DPU-2028
89695692025-10-07DPU-2028
95392502025-10-07DS, DPU-2028
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01M: Quinolone antibacterials
— J01MA: Fluoroquinolone antibacterials, systemic
— J01MA23: Delafloxacin
HCPCS
No data
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544———1——1
Communicable diseasesD003141————1——1
Surgical wound infectionD013530————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDelafloxacin meglumine
INNdelafloxacin
Description
Delafloxacin sold under the brand name Baxdela among others, is a fluoroquinolone antibiotic used to treat acute bacterial skin and skin structure infections.
Classification
Small molecule
Drug classantibacterials (quinolone derivatives)
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Structure (InChI/SMILES or Protein Sequence)
CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F
Identifiers
PDB—
CAS-ID1256037-58-7
RxCUI—
ChEMBL IDCHEMBL2105638
ChEBI ID—
PubChem CID487101
DrugBankDB11943
UNII ID6315412YVF (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Baxdela – Melinta Therapeutics /new/
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 31 documents
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Safety
Black-box Warning
Black-box warning for: Baxdela
Adverse Events
Top Adverse Reactions
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232 adverse events reported
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