Flutemetamol F-18

FDA Drug Profile — Vizamyl

Drug Details

Generic Name
Flutemetamol F-18
Brand Names
Vizamyl
Application Number
NDA203137
Sponsor
GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)
NDC Codes
1
Dosage Forms
SOLUTION
Routes
INTRAVENOUS
Active Ingredients
FLUTEMETAMOL F-18

Indications and Usage

1 INDICATIONS AND USAGE VIZAMYL 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 ( 1 )