AZTREONAM

Post-LOE

Hikma

ANDAINJECTIONINJECTABLE

Approved

Mar 2011

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

AZTREONAM by Hikma is [see microbiology ( )] . Approved for older, no alternative options for the treatment of complicated intra-abdominal infections (ciai) including those caused by the following susceptible gram-negative microorganisms: escherichia coli, klebsiella pneumoniae and 4 more indications. First approved in 2011.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

[see Microbiology ( )] .

Indications (7)

older no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli

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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.

Clinical Trials (20)

NCT06462235Phase 2Recruiting

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

NCT05905055Phase 3Completed

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

NCT05887908Phase 3Completed

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

NCT05639647Phase 2Recruiting

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

NCT04973826Phase 1Completed

Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.

Started Aug 2021

12 enrolled

Healthy