Prescription medicine
Cefiderocol Brand names: Fetroja
Cefiderocol (Fetroja) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cefiderocol FDA label on DailyMed (effective February 24, 2026, Shionogi Inc.); the NDA 209445 record on Drugs@FDA; every cefiderocol label on DailyMed.
Highlights of the record
FDA label of February 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFETROJA is a cephalosporin antibacterial indicated in patients 18 years of age or older for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Complicated Urinary Tract Infections (cUTI), including Pyelonephritis ( 1.1 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) ( 1.2 ) To reduce the development of drug-resistant bacteria
Forms and strengths
- 1 g/10ml
Injection (powder) for solution.
On the market
- Earliest approval on file
- November 14, 2019 Fetroja, Shionogi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 3, 2035 Fetroja 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
- 303 through July 30, 2026
What is cefiderocol used for?
From the label: indications and usageFETROJA is a cephalosporin antibacterial indicated in patients 18 years of age or older for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Complicated Urinary Tract Infections (cUTI), including Pyelonephritis ( 1.1 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of FETROJA and other antibacterial drugs, FETROJA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]
Conditions named in the indications of cefiderocol's FDA labels, with every medicine labeled for each:
From other cefiderocol labelsUrinary tract infections: Infections (cUTIs), Including Pyelonephritis FETROJA ® is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible …
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (Fetroja), Shionogi Inc., effective February 24, 2026 (SPL set 75c0c785-38e0-4049-a6fb-b77581f5b35c), via openFDA; the full label on DailyMed
Is there a generic for cefiderocol (Fetroja)?
No generic cefiderocol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Fetroja injection: the compound patent runs to September 3, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2035 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 cefiderocol?
The FDA Adverse Event Reporting System holds 303 reports that list cefiderocol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 145 are coded as a death and 61 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cefiderocol?
14 other medicines are given the same way (intravenous) and in the same FDA class as cefiderocol or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cefazolin | Urinary tract infections | 7 labelers | $1.07 per vial 1 g vial | No current entry |
| Cefepime | Urinary tract infections | 8 labelers | n/a | A presentation being discontinued |
| Cefoxitin | Urinary tract infections | 5 labelers | n/a | No current entry |
| Ceftriaxone | Urinary tract infections | 7 labelers | $1.44 per vial 1 g vial | No current entry |
| Cefuroxime | Urinary tract infections | 2 labelers | n/a | No current entry |
| Avibactam and ceftazidime | Urinary tract infections | none listed | n/a | No current entry |
| Cefepime and zidebactam | Urinary tract infections | none listed | n/a | No current entry |
| Ceftolozane and tazobactam | Urinary tract infections | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as cefiderocol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cefiderocol
- 14 medicines for the same use
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Cefiderocol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other