NDAINJECTIONINJECTABLEPriority Review
Approved
Oct 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
MEFOXIN (cefoxitin sodium) by Merck & Co. is clinical pharmacology clinical pharmacology following an intravenous dose of 1 gram, serum concentrations were 110 mcg/ml at 5 minutes, declining to less than 1 mcg/ml at 4 hours. Approved for serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below, infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy and 2 more indications. First approved in 1978.
Drug data last refreshed 6d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MEFOXIN (cefoxitin sodium) is a second-generation cephalosporin antibiotic administered intravenously that acts as a bactericidal agent by inhibiting bacterial cell wall synthesis. It is indicated for serious infections caused by susceptible Gram-positive, Gram-negative, and anaerobic bacteria, as well as for surgical prophylaxis in gastrointestinal, gynecological, and obstetric procedures. The drug has activity against beta-lactamase-producing organisms, making it suitable for polymicrobial infections.
LOE Approaching
As a legacy injectable antibiotic nearing loss of exclusivity, teams are focused on cost management and maintaining volume through institutional relationships rather than growth expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Clinical Pharmacology Following an intravenous dose of 1 gram, serum concentrations were 110 mcg/mL at 5 minutes, declining to less than 1 mcg/mL at 4 hours. The half-life after an intravenous dose is 41 to 59 minutes. Approximately 85 percent of cefoxitin is excreted…
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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.