SPECTRACEF
LOE Approachingcefditoren pivoxil
NDAORALTABLET
Approved
Aug 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
SPECTRACEF (cefditoren pivoxil) is clinical pharmacology pharmacokinetics absorption oral bioavailability following oral administration, cefditoren pivoxil is absorbed from the gastrointestinal tract and hydrolyzed to cefditoren by esterases. Approved for mild to moderate infections in adults, adolescents (12 years of age, older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below. First approved in 2001.
Drug data last refreshed 1h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPECTRACEF (cefditoren pivoxil) is an oral third-generation cephalosporin antibiotic that treats mild to moderate bacterial infections in adults and adolescents aged 12+. It works by inhibiting bacterial cell wall synthesis through beta-lactam mechanism of action.
LOE Approaching
Product is approaching loss of exclusivity with limited ongoing commercial investment, suggesting a contracting brand team focused on transition planning and managed decline.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics Absorption Oral Bioavailability Following oral administration, cefditoren pivoxil is absorbed from the gastrointestinal tract and hydrolyzed to cefditoren by esterases. Maximal plasma concentrations (C max ) of cefditoren under fasting conditions average 1.8 ±…
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.