Prescription medicine
Flutemetamol f 18 Brand names: Vizamyl
Flutemetamol f 18 (Vizamyl) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the flutemetamol f 18 FDA label on DailyMed (effective April 6, 2026, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)); the NDA 203137 record on Drugs@FDA; every flutemetamol f 18 label on DailyMed.
Highlights of the record
FDA label of April 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products VIZAMYL is a radioactive diagnosti
Forms and strengths
Solution.
On the market
- Earliest approval on file
- October 25, 2013 Vizamyl, Ge Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 16, 2028 Vizamyl 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
- 463 through July 30, 2026
What is flutemetamol f 18 used for?
From the label: indications and usageVIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products VIZAMYL is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products […]
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (Vizamyl), GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026 (SPL set b3558f16-8f9a-4e55-8d9c-836427ebaa57), via openFDA; the full label on DailyMed
Is there a generic for flutemetamol f 18 (Vizamyl)?
No generic flutemetamol f 18 is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Vizamyl injection, the last expiring on September 16, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2028 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 flutemetamol f 18?
The FDA Adverse Event Reporting System holds 463 reports that list flutemetamol f 18 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 29 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 next?
- Other radioactive diagnostic agents
- the pharmacologic class, with prices and generics
- Flutemetamol f 18 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other