NDAINHALATIONSOLUTION
Approved
Dec 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
KITABIS PAK (tobramycin) by Viatris is [see microbiology ()]. First approved in 2014.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KITABIS PAK is an inhaled tobramycin solution approved for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. Tobramycin is an aminoglycoside antibacterial that disrupts bacterial protein synthesis via ribosomal inhibition. The inhalation route delivers high local lung concentrations while minimizing systemic exposure.
Peak
Peak-stage product in a specialized rare disease market with stable commercial positioning; team structure focused on maintenance and specialty distribution rather than aggressive growth.
Mechanism of Action
[see Microbiology ()].
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)
Tobramycin Injection to Prevent Infection in Open Fractures
Started Jan 2022
600 enrolled
Wound InfectionFractures, OpenSurgical Site Infection
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Started Oct 2018
15 enrolled
Prosthetic Joint Infection
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
Started Jul 2017
35 enrolled
Ototoxicity
Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Started Feb 2017
107 enrolled
Non-cystic Fibrosis Bronchiectasis
Addition of Tobramycin Inhalation in the Treatment of Ventilator Associated Pneumonia
Started Mar 2015
80 enrolled
Ventilator Associated Pneumonia (VAP)
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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.