Ioflupane I-123

FDA Drug Profile — DaTscan

Drug Details

Generic Name
Ioflupane I-123
Brand Names
DaTscan
Application Number
NDA022454
Sponsor
Medi-Physics Inc. dba GE Healthcare.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
IOFLUPANE I-123

Indications and Usage

1 INDICATIONS AND USAGE DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). DATSCAN is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). ( 1 )