NDAORALTABLET
Approved
May 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
ZITHROMAX (azithromycin dihydrate) by Pfizer is drug. First approved in 2002.
Drug data last refreshed 13h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZITHROMAX (azithromycin dihydrate) is an oral macrolide antibiotic approved in 2002 for bacterial infections. It works by inhibiting bacterial protein synthesis, making it effective against a broad spectrum of gram-positive and gram-negative organisms. Patients across multiple infection types rely on this established, well-tolerated agent.
LOE Approaching
With LOE approaching and moderate competitive pressure (30/100), the brand team is likely transitioning to lifecycle management and generic transition planning, suggesting smaller but specialized teams focused on market defense.
Mechanism of Action
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Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Started Dec 2013
8 enrolled
PharyngitisTonsillitis
Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
Started Oct 2009
502 enrolled
Bacterial Infections
Fed Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg
Started May 2005
54 enrolled
Healthy
Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg
Started Apr 2005
54 enrolled
Healthy
Zithromax EV in Community-Acquired Pneumonia (CAP)
Started Nov 2003
151 enrolled
Pneumonia
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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.