NDAORALTABLETPriority Review
Approved
Jun 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ZITHROMAX (azithromycin) by Pfizer is drug. Approved for development of drug-resistant bacteria, maintain the effectiveness of azithromycin for oral suspension, other antibacterial drugs and 4 more indications. First approved in 1996.
Drug data last refreshed 11h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZITHROMAX (azithromycin) is an oral macrolide antibiotic approved in 1996 used to treat bacterial infections caused by susceptible organisms. It works by inhibiting bacterial protein synthesis to prevent the development of drug-resistant bacteria and maintain therapeutic effectiveness.
LOE Approaching
Product approaching loss of exclusivity; commercial teams likely focused on lifecycle extension, generic transition planning, and maintaining market share against growing generic competition.
Mechanism of Action
drug. [see Microbiology ()]
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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.