NDAINJECTIONINJECTABLE
Approved
Dec 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
CEFOTAN (cefotetan) by R-Pharm US is clinical pharmacology high plasma levels of cefotetan are attained after intravenous and intramuscular administration of single doses to normal volunteers. First approved in 1985.
Drug data last refreshed 45m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cefotetan is a second-generation cephalosporin antibiotic administered via intravenous or intramuscular injection. It works by inhibiting bacterial cell wall synthesis and demonstrates bactericidal activity against a broad spectrum of pathogens, including some beta-lactamase-producing organisms. The drug achieves therapeutic concentrations across multiple body tissues and fluids, making it suitable for serious infections in various anatomical sites.
LOE Approaching
As an older injectable antibiotic approaching loss of exclusivity with moderate competitive pressure (30/100), the brand team is likely contracting and focused on cost management and retention in hospital formularies rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY High plasma levels of cefotetan are attained after intravenous and intramuscular administration of single doses to normal volunteers. PLASMA CONCENTRATIONS AFTER 1 GRAM IV OR IM DOSE Mean Plasma Concentration (mcg/mL) Time After Injection Route 15 min 30 min 1 h 2 h 4 h 8 h 12…
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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.