NDAINTRAVENOUSPOWDER
Approved
May 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
CEFAZOLIN SODIUM (cefazolin) by R-Pharm US is [see microbiology (12. First approved in 2023.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cefazolin sodium is a first-generation cephalosporin antibiotic administered intravenously as a powder for reconstitution. It inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins, making it effective against gram-positive and some gram-negative bacteria. This IV formulation is commonly used for surgical prophylaxis and treatment of serious infections in hospitalized patients.
Growth
Product is in growth phase with moderate competitive pressure (30%), suggesting expanding market opportunity and potential team growth in commercial and medical affairs roles.
Mechanism of Action
[see Microbiology (12.4)] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults
Started Apr 2022
12 enrolled
Infections
Cefazolin PK Study 3g vs 2g
Started Feb 2022
24 enrolled
Healthy
Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects
Started Nov 2017
61 enrolled
Postoperative Infection
Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
Started Sep 2017
0Obesity
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Started Jul 2013
9 enrolled
SepsisPrematurity
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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.