NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZACTAM (aztreonam) is a monobactam antibiotic administered by injection, approved in 1986 for treating gram-negative bacterial infections. It is structurally distinct from beta-lactams and is valuable for patients with penicillin allergies who require beta-lactam therapy. The drug works by inhibiting bacterial cell wall synthesis, making it bactericidal.
$0.207MPart D
LOE ApproachingDeclining
This mature product with declining commercial trajectory likely operates with a lean team focused on sustained profitability and managed care negotiations rather than expansion.
Mechanism of Action
Pharmacologic Class:
Monobactam Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
Started Sep 2024
48 enrolled
Gram-negative Bacterial Infection
P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales
Started Sep 2023
126 enrolled
Complicated Urinary Tract InfectionAcute PyelonephritisHospital-acquired Bacterial Pneumonia+2 more
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
Started May 2023
614 enrolled
Complicated Urinary Tract InfectionAcute PyelonephritiscUTI+1 more
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
Started Apr 2023
48 enrolled
Gram-negative Bacterial Infections
Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.
Started Aug 2021
12 enrolled
Healthy
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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.