NDAINTRAVENOUSPOWDER
Approved
Oct 2010
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
6
Data completeness
5/8 — Partial
TEFLARO (ceftaroline fosamil) by AbbVie is [see microbiology ()] . First approved in 2010.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEFLARO (ceftaroline fosamil) is a fifth-generation cephalosporin antibiotic administered intravenously as a powder for reconstitution. It is indicated for bacterial skin and soft tissue infections and community-acquired bacterial pneumonia. The drug works by inhibiting bacterial cell wall synthesis, making it effective against both gram-positive and gram-negative pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
$11MPart D
PeakStable
4.6 years to LOEThe product remains at peak commercial maturity with modest Medicare spending; marketing teams are focused on maintaining market position against high competitive pressure rather than growth initiatives.
Mechanism of Action
[see Microbiology ()] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
Started Jun 2014
4 enrolled
Complicated Skin and Soft Tissue Infection
A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers
Started Aug 2013
48 enrolled
PharmacokineticsOpen LabelCAZ-AVI+3 more
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
Started Oct 2012
49 enrolled
Infections
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Started May 2012
802 enrolled
Complicated Skin and Soft Tissue Infection
Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA
Started Feb 2012
174 enrolled
Skin Diseases, InfectiousStaphylococcal Skin Infections
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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.