xenon Xe 129 hyperpolarized

FDA Drug Profile — XENOVIEW

Drug Details

Generic Name
xenon Xe 129 hyperpolarized
Brand Names
XENOVIEW
Application Number
NDA214375
Sponsor
Polarean, Inc.
NDC Codes
5
Dosage Forms
GAS
Routes
RESPIRATORY (INHALATION)
Active Ingredients
XENON XE-129, HYPERPOLARIZED, HELIUM, NITROGEN, XENON XE-129

Indications and Usage

1 INDICATIONS AND USAGE XENOVIEW ® , prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. ( 1 )