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ceftriaxone

Generic: CEFTRIAXONE SODIUM·Brand: CEFTRIAXONE, CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM, ROCEPHIN, ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER

ceftriaxone: developed by 1 company · 1 clinical trial tracked · 2 FDA decisions.

ceftriaxone evidence translation

What we can confirm

2 FDA records · 1 tracked trial

What it means

Source-backed records connect ceftriaxone to TEVA; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could ceftriaxone → TEVA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Development Pipeline (1)
CompanyPhase
Teva Pharmaceutical Industries Limited (TEVA)Approved
Clinical Trials (1)

A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

NCT07485010·Phase 2
Not yet recruiting

Primary endpoint: The primary outcome of the Intervention Program is microbiological clearance of Mycobacterium abscessus (MABS) with good tolerance of the interventions.

InterventionalRandomizedopen300 targetStarted 2027-04Completion 2031-07The University of Queensland
FDA Decisions2 records
ApprovalINDICATIONS AND USAGE Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or p(TEVA)FDA ↗
ANDA065262IntravenousInjectable
ApprovalINDICATIONS AND USAGE Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: Lower Respiratory Tract Infections Caused by Streptococcus pneumoniae , Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens . Acute Bacterial Otitis Media Caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone and the comparator. The potentially lower clinical cure rate of ceftriaxone should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES ). Skin and Skin Structure Infections Caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes , Viridans group streptococci, Escherichia coli(TEVA)FDA ↗
ANDA065274OtherInjectable

Frequently asked questions

Who is developing ceftriaxone?

ceftriaxone is being developed by Teva Pharmaceutical Industries Limited.

How many clinical trials involve ceftriaxone?

BioSniper tracks 1 clinical trial involving ceftriaxone.

What is ceftriaxone's latest FDA decision?

The most recent tracked FDA decision for ceftriaxone is Approval for INDICATIONS AND USAGE Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or p, dated June 29, 2006.