NDAORALTABLETPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 20h 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 the treatment of community-acquired bacterial pneumonia (CABP). It represents a novel antibiotic class with a distinct mechanism targeting bacterial protein synthesis. The drug is indicated for adult patients with CABP caused by susceptible pathogens.
Peak6.9 years to LOE
Product is in peak commercial phase with stable market positioning; career growth tied to maintaining market share in competitive respiratory infection 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
XENLETA represents a mid-career opportunity within a niche respiratory antibiotic franchise with stable market presence and extended patent protection. Roles are primarily commercial and medical affairs-focused, supporting a mature product with differentiated positioning in a competitive space.
Brand ManagerMedical Science Liaison
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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.