NDAORALTABLETPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 15h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XENLETA (lefamulin acetate) is an oral pleuromutilin antibiotic approved by the FDA in August 2019 for treating community-acquired bacterial pneumonia (CABP) in adults. It represents a novel class of antibiotics with a distinct mechanism of action targeting bacterial protein synthesis. The drug addresses an unmet need in respiratory infection treatment with oral bioavailability.
Peak6.6 years to LOE
XENLETA is in peak commercial phase with minimal competitive pressure, indicating a focused and potentially lean brand team structure.
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 offers exposure to specialty infectious disease commercialization, novel mechanism positioning, and antibiotic stewardship challenges in a mid-sized franchise. This role is best suited for professionals seeking focused commercial execution in a therapeutic area with high clinical relevance but limited job posting activity.
Brand ManagerProduct Manager
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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.