NDAINJECTIONINJECTABLE
Approved
Jan 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
49
Data completeness
3/8 — Basic
ZITHROMAX (azithromycin dihydrate) by Pfizer is drug. First approved in 1997.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZITHROMAX (azithromycin dihydrate) is a macrolide antibiotic administered via injection 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 injectable formulation is typically reserved for hospitalized patients or those requiring parenteral therapy.
LOE Approaching
As LOE approaches, the injectable ZITHROMAX brand team is likely consolidating and focusing on transition planning rather than growth initiatives.
Mechanism of Action
drug. [see ]
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (49)
A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2)
Started Jun 2020
298 enrolled
COVID-19
Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States
Started Dec 2017
66 enrolled
Bioequivalence
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
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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.