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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 infections—D001424A49
bacterial skin diseases—D017192—
escherichia coli infectionsEFO_1001318D004927B96.20
klebsiella infectionsEFO_1001353D007710—
staphylococcal infections—D013203A49.01
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 insufficiencyD051436N18———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Duchenne muscular dystrophyD0203882—2—26
Allergic bronchopulmonary aspergillosisD001229EFO_0007140B44.81—11——1
Limb-girdle muscular dystrophiesD049288EFO_0010955G71.03——1——1
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/patients—4————4
Renal insufficiencyD051437HP_0000083N191————1
Hepatic insufficiencyD0485501————1
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
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3,577 adverse events reported
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