NDAINHALATIONSOLUTIONPriority Review
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
TOBI (tobramycin) by Viatris (2) is clinical pharmacology: corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. First approved in 1997.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOBI is a tobramycin inhalation solution, an aminoglycoside antibiotic indicated for chronic airway infection management in cystic fibrosis patients. It works by targeting susceptible gram-negative and gram-positive bacteria including Pseudomonas aeruginosa through aminoglycoside bactericidal mechanisms. The drug is delivered via inhalation to achieve high local lung concentrations.
$0.149BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending signals a mature franchise requiring defensive commercial strategy and lifecycle management expertise.
Mechanism of Action
CLINICAL PHARMACOLOGY: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be…
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Photobiomodulation for Cancer-Related Cognitive Impairment
Started Jun 2026
30 enrolled
Cancer-related Cognitive Impairment
The Effect of Photobiomodulation on Microvascular Blood Flow: The Role of Wavelength and Skin Temperature
Started Jan 2026
40 enrolled
Microcirculation
Performance of Tests for Schistosoma Haematobium Diagnosis
Started Feb 2025
801 enrolled
Schistosoma Haematobium
Capturing Autobiographical Memory Formation in Real World Spaces Using Multimodal Recordings
Started Jan 2025
50 enrolled
EpilepsyAutobiographical Memory
A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin
Started Jan 2025
12 enrolled
Drug-drug Interaction Study
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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.