NDAORALTABLET
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 Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CEFZIL (cefprozil) is an oral second-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis through beta-lactam mechanism of action. It is indicated for treatment of bacterial infections including upper and lower respiratory tract infections, otitis media, and skin infections. The drug demonstrates rapid oral absorption with peak plasma concentrations achieved within 1.5 hours and renal clearance accounting for approximately 60% of the administered dose.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating declining revenue trajectory and potential team restructuring.
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,…
Worked on CEFZIL at Engine Biosciences? Share your interview experience or compensation data (+7 days Pro)
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.