NDAORALTABLETPriority Review
Approved
Jun 2017
Lifecycle
Peak
Competitive Pressure
8/100
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 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BAXDELA (delafloxacin meglumine) is a fluoroquinolone antibacterial agent approved for acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive and gram-negative pathogens including MRSA. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, with efficacy correlating to the ratio of free drug AUC to minimal inhibitory concentration (fAUC/MIC). The drug is available as an oral tablet with 58.8% bioavailability and reaches steady-state within approximately three days.
Peak4.7 years to LOE
Product is in peak lifecycle stage at 4.8 years post-approval, likely supported by stable mid-sized commercial team focused on infectious disease specialists and hospital formularies.
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.