NDAINTRAVENOUSPOWDER
Approved
Oct 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
5/8 — Partial
CEFAZOLIN SODIUM (cefazolin) by Hikma is 12. Approved for bacterial infections, surgical site infection, postoperative infection and 4 more indications. First approved in 2022.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cefazolin sodium is a first-generation cephalosporin antibiotic administered intravenously as a powder for injection. It works by inhibiting bacterial cell wall synthesis and is used to treat gram-positive bacterial infections including surgical site infections, osteomyelitis, and bacteremia. The drug is bactericidal and effective against most gram-positive organisms, though resistant to methicillin-resistant staphylococci and gram-negative pathogens.
Peak
At peak lifecycle with 30% competitive pressure, the brand is stable but faces significant generic and alternative antibiotic competition, suggesting a moderately-sized commercial team focused on maintenance rather than expansion.
Mechanism of Action
12.1 Mechanism of Action Cefazolin is an antibacterial drug [see ] . 12.2 Pharmacodynamics The pharmacokinetic/pharmacodynamic relationship for cefazolin has not been evaluated in patients. 12.3 Pharmacokinetics Studies have shown that following intravenous administration of cefazolin for injection…
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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.