CEFIXIME

Post-LOE

cefixime

Inpharmus

ANDAORALFOR SUSPENSION

Approved

Feb 2017

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

CEFIXIME (cefixime) by Inpharmus is [see microbiology ( )] . Approved for the treatment of adults, older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli, proteus mirabilis and 5 more indications. First approved in 2017.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

[see Microbiology ( )] .

Indications (8)

the treatment of adults older with uncomplicated urinary tract infections caused by susceptible isolates of 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 (7)

NCT04349826Phase 4Completed

The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)

Started May 2021

2,150 enrolled

Typhoid Fever

NCT03660488Phase 2Completed

Cefixime for Alternative Syphilis Treatment

Started Sep 2018

58 enrolled

SyphilisEarly Syphilis

NCT03408392Phase 1Completed

Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions

Started Feb 2018

28 enrolled

Infections, Bacterial

NCT03329547Phase 1Withdrawn

A Bioequivalence Study of SKF101804 Cefixime Versus Cefixime Reference Formulation in Healthy Adults Under Fasting Conditions

Started Jan 2018

Infections, Bacterial

NCT02708992Phase 1Completed

Cefixime / Azithromycin pK Study

Started Apr 2016

10 enrolled

Gonorrhoea