NDAINTRAVENOUSPOWDERPriority Review
Approved
Jun 2017
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
BAXDELA (delafloxacin meglumine) by CorMedix is 12. Approved for skin structure infections (absssi) caused by the following susceptible microorganisms: staphylococcus aureus (including methicillin-resistant [mrsa], methicillin-susceptible [mssa] isolates), staphylococcus haemolyticus and 17 more indications. First approved in 2017.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BAXDELA (delafloxacin meglumine) is a fluoroquinolone antibiotic approved for acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive and Gram-negative organisms including MRSA. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, with efficacy correlating to the f AUC/MIC ratio. Available as an intravenous powder formulation, it offers clinical advantages including no QT prolongation and minimal photosensitivity risk versus legacy fluoroquinolones.
Peak8.1 years to LOE
Product is at peak commercial maturity with limited job openings; team size is small and promotional activity may be narrowly focused on specialty care channels.
Mechanism of Action
12.1 Mechanism of Action BAXDELA is an antibacterial drug [see ] . 12.2 Pharmacodynamics The antibacterial activity of delafloxacin appears to best correlate with the ratio of area under the concentration-time curve of free delafloxacin to minimal inhibitory concentration ( f AUC/MIC) for…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.