NDAOPHTHALMICSUSPENSION/DROPS
Approved
Aug 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
TOBRADEX (tobramycin and dexamethasone) by Novartis is corticosteroid hormone receptor agonists [moa]. Approved for aminoglycoside antibacterial [epc]. First approved in 1988.
Drug data last refreshed 7m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOBRADEX is a fixed-dose ophthalmic suspension combining tobramycin (aminoglycoside antibiotic) and dexamethasone (corticosteroid) for topical eye use. It treats bacterial ocular infections with inflammatory components by simultaneously eliminating bacteria and reducing inflammation. The combination addresses both infection and immune response in external eye disease.
LOE Approaching
This 35-year-old product is entering loss-of-exclusivity phase, signaling potential downsizing of commercial teams and transition toward generic defense strategies.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
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
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
Started Oct 2009
357 enrolled
ConjunctivitisKeratitisBlepharitis
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Started Oct 2007
221 enrolled
Ocular Inflammation Associated With Blepharaconjunctivitis
Zylet vs TobraDex in Blepharokeratoconjunctivitis
Started Jan 2007
276 enrolled
Blepharokeratoconjunctivitis
Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
Started Dec 2006
0Post-surgical Inflammation
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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.