NDAORALFOR SUSPENSION
Approved
Sep 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
ZITHROMAX (azithromycin) by Pfizer is drug. First approved in 1994.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZITHROMAX (azithromycin) is an oral macrolide antibiotic approved in 1994 that disrupts bacterial protein synthesis to treat a broad spectrum of respiratory, skin, and sexually transmitted infections. It is a foundational small-molecule antibiotic with decades of clinical use and established safety profiles across diverse patient populations.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); expect portfolio transition focus and consolidation of legacy-stage commercial teams.
Mechanism of Action
drug. [see Microbiology ()]
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Started Nov 2024
8,000 enrolled
Obstetrical ComplicationsLabor and Delivery ComplicationCesarean Delivery
Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition
Started Oct 2024
3,000 enrolled
Malnutrition, ChildSevere Acute Malnutrition
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Started Mar 2024
140 enrolled
Premature Rupture of Membrane
Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations
Started Mar 2024
1,311 enrolled
Chronic Obstructive Pulmonary Disease
Azithromycin Before Induction
Started Aug 2023
400 enrolled
Infections
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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.