CEDAX
LOE Approachingceftibuten dihydrate
NDAORALCAPSULE
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CEDAX (ceftibuten dihydrate) is clinical pharmacology pharmacokinetics absorption cedax capsules ceftibuten is rapidly absorbed after oral administration of cedax capsules. Approved for individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see. First approved in 1995.
Drug data last refreshed 5d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CEDAX (ceftibuten dihydrate) is an oral third-generation cephalosporin antibiotic approved in 1995 for treating mild-to-moderate infections caused by susceptible bacteria. It is rapidly absorbed orally with peak plasma concentrations achieved within 2–3 hours and demonstrates good tissue penetration to bronchial secretions and middle-ear fluid. The drug works by inhibiting bacterial cell wall synthesis, making it effective for respiratory and ear infections in both adults and pediatric patients.
LOE Approaching
As LOE approaches, commercial teams face margin compression and declining market presence; headcount reductions and consolidation are likely in the near term.
Mechanism of Action
CLINICAL PHARMACOLOGY PHARMACOKINETICS Absorption CEDAX CAPSULES Ceftibuten is rapidly absorbed after oral administration of CEDAX Capsules. The plasma concentrations and pharmacokinetic parameters of ceftibuten after a single 400-mg dose of CEDAX Capsules to 12 healthy adult male volunteers (20 to…
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.