TEFLARO (ceftaroline fosamil)
TEFLARO is indicated for the treatment of Acute Bacterial Skin and Skin Structure Infections; Community-Acquired Bacterial Pneumonia.
How TEFLARO Works
Ceftaroline is a bactericidal cephalosporin that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). Its activity against MRSA is attributed to its high affinity for PBP2a, an altered PBP that typically provides resistance to other beta-lactam antibiotics. It also binds to PBP2x in *Streptococcus pneumoniae*. By inhibiting PBP-mediated cross-linking of peptidoglycan, it leads to bacterial cell lysis and death.
Details
- Status
- Prescription
- First Approved
- 2010-10-29
- Patent Cliff
- 2031
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
TEFLARO Approval History
What TEFLARO Treats
2 indicationsTEFLARO is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Bacterial Skin and Skin Structure Infections
- Community-Acquired Bacterial Pneumonia
TEFLARO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TEFLARO
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02806882 Ceftaroline | Chavanet AZ 2014 | Ph 1 | completed | Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF) |
| NCT02335905 results posted | H-35130 TEF-IT-43/IIT-2017-10048 | Ph 1, Ph 2 | completed | Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children |
| NCT02424734 results posted | D3720C00009 C2661002, 2014-003243-34 | Ph 2 | terminated | Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis |
| NCT02202135 results posted | D3720C00001sub | Ph 3 | terminated | Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections. |
| NCT01499277 results posted | D3720C00001 2011-004013-16 | Ph 3 | completed | Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections |
| NCT01645735 results posted | P903-25 | Ph 4 | completed | Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus |
| NCT01669980 | P903-24 | Ph 4 | completed | Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP) |
| NCT01400867 | P903-23 | Ph 2, Ph 3 | completed | Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections |
| NCT01530763 | P903-31 | Ph 2, Ph 3 | completed | Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP) |
| NCT01701219 | CPT-MD-32 | Ph 4 | completed | Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia |
| NCT01298843 | P903-21 | Ph 4 | completed | Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital |
| NCT01666743 | CPT-MD-34 | Ph 4 | withdrawn | Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TEFLARO FDA Label Details
Indications & Usage
FDA Label (PDF)TEFLARO is indicated for the treatment of Acute Bacterial Skin and Skin Structure Infections; Community-Acquired Bacterial Pneumonia.
Pro Intelligence Preview
Deep insights for TEFLARO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.