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Baxdela, Quofenix(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
Baxdela
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Delafloxacin meglumine
Tradename
Company
Number
Date
Products
BAXDELAMelinta TherapeuticsN-208610 RX2017-06-19
1 products, RLD, RS
BAXDELAMelinta TherapeuticsN-208611 RX2017-06-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
baxdelaNew Drug Application2021-02-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infectionsD001424A49
bacterial skin diseasesD017192
escherichia coli infectionsEFO_1001318D004927B96.20
klebsiella infectionsEFO_1001353D007710
staphylococcal infectionsD013203A49.01
streptococcal infectionsEFO_1001476D013290
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
17 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic renal insufficiencyD051436N1811
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Duchenne muscular dystrophyD0203882226
Allergic bronchopulmonary aspergillosisD001229EFO_0007140B44.81111
Limb-girdle muscular dystrophiesD049288EFO_0010955G71.0311
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients44
Renal insufficiencyD051437HP_0000083N1911
Hepatic insufficiencyD04855011
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)
Image (chem structure or protein)
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-ID189279-58-1
RxCUI1927663
ChEMBL IDCHEMBL2105638
ChEBI ID
PubChem CID487101
DrugBankDB11943
UNII ID6315412YVF (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Baxdela - MELINTA THERAPEUTICS, INC. /NEW/
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 645 documents
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Safety
Black-box Warning
Black-box warning for: Baxdela
Adverse Events
Top Adverse Reactions
Mock data
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3,577 adverse events reported
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