Tetrofosmin

FDA Drug Profile — Myoview

Drug Details

Generic Name
Tetrofosmin
Brand Names
Myoview
Application Number
NDA020372
Sponsor
Medi-Physics Inc. dba GE Healthcare
NDC Codes
3
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
TETROFOSMIN

Indications and Usage

1 INDICATIONS AND USAGE MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for the following: Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease ( 1.1 ) Assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease ( 1.2 ) 1.1 Myocardial Perfusion Imaging Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease. 1.2 Ventricular Function Imaging MYOVIEW is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease.