NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 13h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XENLETA (lefamulin acetate) is an intravenous pleuromutilin antibiotic approved in 2019 for treating community-acquired bacterial pneumonia (CABP). It represents a novel mechanism of action targeting bacterial protein synthesis, offering an alternative for patients with resistant pathogens or limited oral options.
Peak9.7 years to LOE
Peak lifecycle stage indicates mature commercial infrastructure with stable team size, though limited public spending data suggests modest market penetration in a competitive CABP space.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on XENLETA positions you in the mature antibiotic market where success depends on prescriber education, hospital formulary placement, and reimbursement navigation rather than breakthrough clinical data. Career growth on this asset is incremental and stabilizing rather than high-velocity expansion.
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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.