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 Ioflupane I 123 Injection 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). Ioflupane I 123 Injection 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 )