NDAINTRAVENOUSSOLUTIONPriority 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 intravenous pleuromutilin antibiotic approved in August 2019 for treating bacterial infections. It represents a novel mechanism of action in the antibiotic class, targeting bacterial protein synthesis. The IV formulation allows for hospital-based acute care settings with potential for oral step-down therapy.
Peak10.1 years to LOE
Product is in peak commercial phase with opportunity for expansion, though limited current competitive pressure suggests smaller dedicated team size relative to blockbuster programs.
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 stable employment in a mature antibiotic portfolio at peak commercial phase. The limited current linked jobs and zero competitive pressure suggest this is a specialized, focused team environment ideal for deep product expertise building and hospital-channel mastery.
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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.