NDAINTRAVENOUSPOWDERPriority Review
Approved
Dec 2014
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZERBAXA is a fixed-dose combination of ceftolozane (a fifth-generation cephalosporin) and tazobactam (a beta-lactamase inhibitor) administered intravenously as a powder for reconstitution. It is indicated for complicated urinary tract infections (cUTI) and hospital-acquired/ventilator-associated bacterial pneumonia (HAP/VABP) caused by susceptible gram-negative organisms, including Pseudomonas aeruginosa. The mechanism combines broad-spectrum beta-lactam activity with beta-lactamase inhibition to overcome resistance mechanisms in difficult-to-treat pathogens.
$0.013BPart D
Peak9.5 years to LOEEstablished product at peak commercial maturity with stable niche positioning in serious gram-negative infection market; team size likely maintained but growth-focused recruitment limited.
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
ZERBAXA roles are concentrated in specialty hospital-focused commercial functions, with emphasis on infectious disease specialists, hospital formulary teams, and managed care negotiations. Career growth is tied to defensive market maintenance and geographic expansion rather than launch-phase innovation; stability is high but advancement may require transition to earlier-stage assets within 5-7 years.
Brand 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.