NDAORALFOR SUSPENSION
Approved
Aug 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
4/8 — Partial
BANAN (cefpodoxime proxetil) by Daiichi Sankyo is clinical pharmacology absorption and excretion: cefpodoxime proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime. Approved for development of drug-resistant bacteria, maintain the effectiveness of cefpodoxime proxetil, other antibacterial drugs and 3 more indications. First approved in 1992.
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BANAN (cefpodoxime proxetil) is an oral third-generation cephalosporin prodrug approved in 1992 for treating bacterial infections caused by susceptible organisms. It is absorbed from the GI tract and de-esterified to its active metabolite cefpodoxime, achieving therapeutic concentrations in skin, tonsil, and other tissues. The drug is indicated for respiratory, urinary, and skin infections where antibiotic-resistant bacteria are a concern.
LOE Approaching
Product is approaching loss of exclusivity with minimal current spending visibility, signaling a contracting commercial team focused on generic transition planning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Absorption and Excretion: Cefpodoxime proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime. Following oral administration of 100 mg of cefpodoxime proxetil to fasting subjects, approximately 50% of the…
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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.