NDAORALFOR SUSPENSION
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
CEFZIL (cefprozil) by Engine Biosciences is clinical pharmacology the pharmacokinetic data were derived from the capsule formulation; however, bioequivalence has been demonstrated for the oral solution, capsule, tablet, and suspension formulations under fasting conditions. First approved in 1991.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CEFZIL (cefprozil) is an oral second-generation cephalosporin antibiotic approved in 1991 for treating bacterial infections. It works by inhibiting bacterial cell wall synthesis through beta-lactam mechanism of action. The drug is administered orally in suspension, capsule, tablet, or powder formulations with rapid absorption (95% bioavailability) and a short half-life of approximately 1.3 hours in healthy subjects.
LOE Approaching
Product is in late-stage lifecycle with declining exclusivity; career roles will focus on transition planning and generic competition mitigation rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY The pharmacokinetic data were derived from the capsule formulation; however, bioequivalence has been demonstrated for the oral solution, capsule, tablet, and suspension formulations under fasting conditions. Following oral administration of cefprozil to fasting subjects,…
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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.