NDAINJECTIONINJECTABLE
Approved
Jan 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
49
Data completeness
4/8 — Partial
ZITHROMAX (azithromycin dihydrate) by Pfizer is drug. Approved for infection. First approved in 1997.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZITHROMAX (azithromycin dihydrate) is an injectable macrolide antibiotic approved in 1997 for the treatment of bacterial infections, including community-acquired pneumonia. It works by inhibiting bacterial protein synthesis to achieve bacteriostatic effects against susceptible organisms.
LOE Approaching
With LOE approaching and no recent spending data available, the brand team is likely focused on defensive strategies and lifecycle management rather than growth initiatives.
Mechanism of Action
drug. [see ]
Indications (1)
Clinical Trials (49)
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Started Dec 2013
8 enrolled
PharyngitisTonsillitis
Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)
Started Mar 2013
21 enrolled
Legionnaires' DiseaseLegionella Pneumophila Infections
Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)
Started Sep 2012
403 enrolled
PneumoniaPelvic Inflammatory Disease
Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
Started Oct 2010
2,891 enrolled
Intermittent Preventive Treatment In Pregnancy (IPTp)
A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects
Started Apr 2010
40 enrolled
Malaria Prophylaxis
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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.