NDAINHALATIONSOLUTIONPriority Review
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — 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. Approved for cystic fibrosis, conjunctivitis, pseudomonas aeruginosa infection and 6 more indications. First approved in 1997.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOBI (tobramycin) is an aminoglycoside antibiotic administered via inhalation as a solution. It treats bacterial infections including cystic fibrosis-associated Pseudomonas aeruginosa and other susceptible gram-negative and gram-positive organisms by inhibiting bacterial protein synthesis. The drug is used across multiple routes (inhalation, topical, systemic) for respiratory, ocular, and wound infections.
$0.149MPart D
LOE ApproachingProduct is approaching loss of exclusivity with minimal Part D uptake (21 claims, $149K spend in 2023), signaling a mature, niche market with likely reduced commercial investment and team contraction.
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 (9)
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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.