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 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BAXDELA is a next-generation fluoroquinolone IV antibiotic containing delafloxacin meglumine, approved for acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive and Gram-negative pathogens including MRSA. The drug works through inhibition of bacterial DNA gyrase and topoisomerase IV, with pharmacodynamic activity best correlating to the free drug AUC/MIC ratio.
Peak7.9 years to LOE
BAXDELA is in peak commercial phase with established market presence in IV antibiotics, though with limited publicly available spending data suggesting a niche positioning within the ABSSSI market.
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.