NDAOPHTHALMICSOLUTION/DROPS
Approved
Apr 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
4/8 — Partial
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZASITE is an ophthalmic solution containing azithromycin monohydrate, a macrolide antibiotic approved in 2007 for treating bacterial eye infections. Administered as topical drops, it provides sustained antimicrobial activity in ocular tissues. The drug targets patients with bacterial conjunctivitis and related ophthalmic infections.
$0.067BPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with minimal Part D penetration; brand team is likely focused on defending market share against generic and OTC alternatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Study to Determine the Effect of Azasite on Corneal Surface Irregularity
Started Mar 2013
0Meibomian Gland Dysfunction
A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis
Started Apr 2010
122 enrolled
Blepharitis
Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis
Started Apr 2008
20 enrolled
Blepharitis
Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis
Started Mar 2008
25 enrolled
Blepharitis
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Started Mar 2008
37 enrolled
Bacterial InfectionsEye 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.