Vizamyl FDA Approval History

Last updated by Judith Stewart, BPharm on July 1, 2025.

FDA Approved: Yes (First approved October 25, 2013)
Brand name: Vizamyl
Generic name: flutemetamol F 18
Dosage form: Injection
Company: GE Healthcare
Treatment for: Diagnosis and Investigation

Vizamyl (flutemetamol F 18) is a PET amyloid imaging agent for the evaluation of Alzheimer's disease and other cognitive disorders.

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.

Development timeline for Vizamyl

Date	Article
Jun 24, 2025	Approval FDA Approves Expanded Indications for GE HealthCare’s Vizamyl PET Imaging Agent for Beta Amyloid Detection, Enabling More Precise Care for Alzheimer’s Patients
Oct 25, 2013	Approval FDA Approves Vizamyl Brain Imaging Drug to Help Evaluate Patients for Alzheimer’s Disease, Dementia
Jan 8, 2013	GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F]Flutemetamol in the United States and Europe

Further information

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Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Vizamyl FDA Approval History

Development timeline for Vizamyl

See also

Further information