Vizamyl FDA Approval History

Last updated by Judith Stewart, BPharm on June 22, 2020.

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 or other cognitive disorders.

Development timeline for Vizamyl

Date	Article
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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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

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Vizamyl FDA Approval History

Development timeline for Vizamyl

See also

Further information