Prescription medicine

Ceftaroline Brand names: Teflaro

Ceftaroline (Teflaro) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed

Check it at the source: the ceftaroline FDA label on DailyMed (effective May 29, 2026, Apotex Corp.); the NDA 200327 record on Drugs@FDA; every ceftaroline label on DailyMed.

Highlights of the record

FDA label of May 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
INDICATIONS AND USAGE Ceftaroline fosamil for injection is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ( 1.1 ) Community-acquired bacterial pneumonia

Forms and strengths

400 mg/20ml
600 mg/20ml

Injection (powder) (lyophilized) for solution; powder for solution.

On the market

Earliest approval on file: October 29, 2010 Teflaro, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 1 first September 21, 2021; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC): 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Last listed patent: February 10, 2031 Teflaro injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 808 through July 30, 2026

What is ceftaroline used for?

From the label: indications and usage
INDICATIONS AND USAGE Ceftaroline fosamil for injection is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ( 1.1 ) Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftaroline fosamil for injection and other antibacterial drugs, ceftaroline fosamil for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]

FDA pharmacologic class: Cephalosporin Antibacterial.

Source: FDA drug label (Ceftaroline Fosamil), Apotex Corp., effective May 29, 2026 (SPL set 3cee3c08-ed60-06c5-ac49-103b7ad2ef5f), via openFDA; the full label on DailyMed

Is there a generic for ceftaroline (Teflaro)?

The FDA approved the first generic ceftaroline on September 21, 2021. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists ceftaroline from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 2 patents for Teflaro injection, the last expiring on February 10, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2010 earliest approval on file
2021 first generic approved
2031 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for ceftaroline?

The FDA Adverse Event Reporting System holds 808 reports that list ceftaroline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 151 are coded as a death and 312 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Off Label Use (a use or a product term, not a reaction)135
Neutropenia (named in the label)74
Drug Ineffective (a use or a product term, not a reaction)64
Acute Kidney Injury51
Death (an outcome recorded in the report)47
Rash (named in the label)46
Agranulocytosis (named in the label)39
Thrombocytopenia (named in the label)37

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other cephalosporins: the pharmacologic class, with prices and generics
Ceftaroline side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other