Prescription medicine

Fluciclovine f 18 Brand names: Axumin

Fluciclovine f 18 (Axumin) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the fluciclovine f 18 FDA label on DailyMed (effective March 5, 2025, Blue Earth Diagnostics); the NDA 208054 record on Drugs@FDA; every fluciclovine f 18 label on DailyMed.

Highlights of the record

FDA label of March 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Forms and strengths

Injection (solution).

On the market

Earliest approval on file: May 27, 2016 Axumin, Blue Earth; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: April 23, 2042 Axumin 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: 100 through July 30, 2026

What is fluciclovine f 18 used for?

From the label: indications and usage
Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment ( 1 ).

FDA pharmacologic class: Radioactive Diagnostic Agent.

Source: FDA drug label (Axumin), Blue Earth Diagnostics, effective March 5, 2025 (SPL set 389a502e-a7d5-43dd-b6bf-f022ff23f3b9), via openFDA; the full label on DailyMed

Is there a generic for fluciclovine f 18 (Axumin)?

No generic fluciclovine f 18 is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 8 patents for Axumin injection, the last expiring on April 23, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2016 earliest approval on file
2042 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 fluciclovine f 18?

The FDA Adverse Event Reporting System holds 100 reports that list fluciclovine f 18 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 2 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

Positron Emission Tomogram Abnormal22
No Adverse Event (a use or a product term, not a reaction)18
Therapeutic Response Unexpected18
Scan Abnormal11
False Negative Investigation Result7
Drug Ineffective (a use or a product term, not a reaction)6
Off Label Use (a use or a product term, not a reaction)6
Injection Site Extravasation5

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 radioactive diagnostic agents: the pharmacologic class, with prices and generics
Fluciclovine f 18 side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other