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 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 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOBI (tobramycin) is an inhaled aminoglycoside antibiotic solution approved in 1997 for inhalation delivery to the lungs. It is used to treat Pseudomonas aeruginosa airway infections, primarily in cystic fibrosis patients. Tobramycin works by inhibiting bacterial protein synthesis in susceptible gram-negative and gram-positive organisms.
$0.149BPart D
LOE ApproachingStable
Long-established inhaled antibiotic nearing loss of exclusivity with modest Part D utilization signals a mature, stable commercial team managing decline.
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 Oct 2026
30 enrolled
Cancer-related Cognitive Impairment
A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers
Started Sep 2026
168 enrolled
Pancreatobiliary CancersPancreatic Ductal Adenocarcinoma
Photobiomodulation Therapy for Pain Control in Post-Operative Total Knee Arthroplasty Patients: A Pilot Study
Started Aug 2026
15 enrolled
Pain ManagementTKAPost Operative Analgesia+1 more
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
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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.