Ceftaroline Fosamil

Sold as Teflaro. Every FDA application for this active ingredient: 1 branded and 1 generic.

As of Nov 15, 2026, FDA lists 2 applications for Ceftaroline Fosamil (sold as Teflaro), first approved Oct 29, 2010, with 5 new uses approved and 0 published complete response letters.

First approved: Oct 29, 2010
Applications: 2
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $15.0M
First approved in the EU: Aug 22, 2012

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Teflaro	Part D	$14.8M	+18%	1,047
Teflaro	Part B	$223K	-3%	89
Ceftaroline Fosamil	Part D	$0K	New	0

Approvals in the EU (EMA)

First approved in the EU 22 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Zinforo, new substancePfizer Ireland Pharmaceuticals · Aug 22, 2012

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Combination Antibiotic Therapy for Staphylococcus Aureus BacteremiaStaphylococcus Aureus Bacteremia · Intermountain Health Care, Inc.	Phase 4	Recruiting	Jan 29, 2026
Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary InfectionNon-Tuberculous Mycobacterial (NTM) Pneumonia, Mycobacterium Abscessus Infection · Vancouver Coastal Health	Phase 1	Enrolling by invitation	Nov 14, 2025
Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?Staphylococcus Aureus Bacteremia · West Virginia University	Phase 4	Enrolling by invitation	Aug 29, 2025
Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)Community-acquired Pneumonia · Hellenic Institute for the Study of Sepsis	Phase 3	Recruiting	Mar 5, 2024
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired PneumoniaRespiratory Tract Diseases, Influenza (Pandemic) · UMC Utrecht	Phase 3	Recruiting	Apr 13, 2016

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 29, 2010	TeflaroNDA 200327 · New molecular entity	Abbvie	17	Marketed
Sep 21, 2021	Ceftaroline FosamilANDA 208075	Apotex	2	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA