NDAINHALATIONFOR SOLUTION
Approved
Feb 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
CAYSTON (aztreonam) by Gilead Sciences is 12. First approved in 2010.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAYSTON is an inhaled monobactam antibiotic (aztreonam) approved in 2010 for treating Pseudomonas aeruginosa lung infections in cystic fibrosis patients. It works by binding to penicillin-binding proteins and inhibiting bacterial cell wall synthesis, with peak sputum concentrations of 726–984 mcg/g achieved without systemic accumulation. The formulation is specifically designed for direct pulmonary delivery via inhalation, achieving minimal plasma levels (0.55–0.67 mcg/mL) compared to intravenous dosing.
$34MPart D
LOE ApproachingProduct is in LOE-approaching phase with modest Medicare Part D spending ($34M, 2023), indicating a niche but stable market with limited team expansion opportunity.
Mechanism of Action
12.1 Mechanism of Action Aztreonam is an antibacterial drug [see ] . 12.3 Pharmacokinetics Sputum Concentrations Sputum aztreonam concentrations exhibited considerable variability between patients receiving CAYSTON (75 mg) in clinical trials. The mean sputum concentration 10 minutes following the…
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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.