NDAINJECTIONINJECTABLE
Approved
May 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (cefepime hydrochloride) by B. Braun is 12. Approved for pneumonia (moderate to severe) caused by streptococcus pneumoniae (including cases associated with concurrent bacteremia), pseudomonas aeruginosa, klebsiella pneumoniae and 4 more indications. First approved in 2010.
Drug data last refreshed 7m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cefepime hydrochloride is a fourth-generation cephalosporin antibiotic administered intravenously in a duplex container with dextrose. It treats moderate-to-severe bacterial infections including pneumonia, skin/skin structure infections, and sepsis caused by gram-positive and gram-negative organisms. The drug works by inhibiting bacterial cell wall synthesis, with efficacy correlating to time above MIC.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%) signals contraction phase; brand teams should prepare for generic erosion and cost management strategies.
Mechanism of Action
12.1 Mechanism of Action Cefepime is a cephalosporin antibacterial drug [see ]. 12.2 Pharmacodynamics Similar to other beta-lactam antimicrobial agents, the time that the unbound plasma concentration of cefepime exceeds the MIC of the infecting organism has been shown to best correlate with…
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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.