NDAORALFOR SUSPENSION
Approved
Apr 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
SUPRAX (cefixime) by Pfizer is [see microbiology ( )] . First approved in 1989.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUPRAX (cefixime) is an oral third-generation cephalosporin antibiotic approved in 1989 for treating infections including gonorrhea, typhoid fever, bacterial vaginitis, and cervicitis. It works by inhibiting bacterial cell wall synthesis, making it bactericidal against susceptible gram-positive and gram-negative organisms.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting a consolidating team focused on managed decline and generic transition strategy.
Mechanism of Action
[see Microbiology ( )] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)
Started May 2021
2,150 enrolled
Typhoid Fever
Cefixime for Alternative Syphilis Treatment
Started Sep 2018
58 enrolled
SyphilisEarly Syphilis
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
A Bioequivalence Study of SKF101804 Cefixime Versus Cefixime Reference Formulation in Healthy Adults Under Fasting Conditions
Started Jan 2018
0Infections, Bacterial
Cefixime / Azithromycin pK Study
Started Apr 2016
10 enrolled
Gonorrhoea
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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.