NDAORALTABLET
Approved
May 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
ZITHROMAX (azithromycin dihydrate) by Pfizer is drug. First approved in 2002.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZITHROMAX (azithromycin dihydrate) is an oral macrolide antibiotic approved by the FDA in 2002 for treating bacterial infections across multiple indications. It works by inhibiting bacterial protein synthesis, making it effective against a broad spectrum of gram-positive and gram-negative organisms. The drug is formulated as tablets for convenient oral administration.
LOE Approaching
As LOE approaches, the brand team is likely focused on defending market share against generics and optimizing operational efficiency rather than growth initiatives.
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 (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
Career Relevance
Working on ZITHROMAX in an LOE-approaching phase offers exposure to mature product management, generic defense strategies, and lifecycle optimization—valuable skills but with limited growth trajectory. Career development on this product is best suited for professionals seeking operational excellence, market access expertise, or transition roles rather than high-growth brand building.
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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.