NDAINTRAVENOUSPOWDER
Approved
Oct 2010
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
6
Data completeness
6/8 — Strong
TEFLARO (ceftaroline fosamil) by AbbVie is [see microbiology ()] . Approved for complicated skin and soft tissue infection, community acquired pneumonia. First approved in 2010.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEFLARO (ceftaroline fosamil) is a 5th-generation cephalosporin antibiotic administered intravenously as a powder for reconstitution. It is indicated for treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) in adults and pediatric patients (≥12 days postnatal age), with activity against both Gram-positive pathogens including methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative organisms. The drug represents an important option for serious infections where resistance patterns limit older beta-lactam use, positioning it as a standard-of-care therapy for complicated skin infections and pneumonia in hospitalized patients.
$0.0BPart D
4.8 years to LOEMechanism of Action
[see Microbiology ()] .
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.