NDAINJECTIONINJECTABLE
Approved
Dec 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
AZITHROMYCIN (azithromycin) by Entera Bio is drug. First approved in 2006.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Azithromycin is a macrolide antibiotic available as an injectable formulation used to treat bacterial infections across multiple therapeutic areas. The drug works by inhibiting bacterial protein synthesis, making it effective against a broad spectrum of gram-positive and gram-negative organisms. It represents a mature, widely-used antimicrobial with established clinical utility.
LOE Approaching
With LOE approaching, the brand team is likely in a defensive posture focused on lifecycle management and cost optimization rather than growth initiatives.
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.