NDAORALFOR SUSPENSION
Approved
Oct 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
ZITHROMAX (azithromycin dihydrate) by Pfizer is drug. Approved for infection. First approved in 1995.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZITHROMAX (azithromycin dihydrate) is an oral macrolide antibiotic approved in 1995 for the treatment of bacterial infections. It works by inhibiting bacterial protein synthesis, making it effective against a broad spectrum of gram-positive and gram-negative organisms. The suspension formulation enables flexible dosing across adult and pediatric populations.
LOE Approaching
LOE-stage product with moderate competitive pressure (30%) signals transition planning; brand teams are likely consolidating resources and managing decline rather than scaling.
Mechanism of Action
drug. [see ]
Indications (1)
Clinical Trials (4)
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
Zithromax EV in Community-Acquired Pneumonia (CAP)
Started Nov 2003
151 enrolled
Pneumonia
A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications
Started Jan 2003
157 enrolled
Healthy
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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.