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 9m 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 works by inhibiting bacterial cell wall synthesis, making it effective against a broad spectrum of gram-positive and some gram-negative bacteria. This generic injectable antibiotic is used primarily for surgical prophylaxis and serious bacterial infections in hospitalized patients.
Growth
Recent NDA approval positions this as a growing product, though limited commercial data suggests early-stage market penetration; commercial team expansion likely depends on market adoption velocity.
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.