Application Nr Approved Date Route Status External Links
ANDA208413 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Choline C 11 Injection Is Indicated For Positron Emission Tomography (Pet) Imaging Of Patients With Suspected Prostate Cancer Recurrence And Non-Informative Bone Scintigraphy, Computerized Tomography (Ct) Or Magnetic Resonance Imaging (Mri). In These Patients, 11 C-Choline Pet Imaging May Help Identify Potential Sites Of Prostate Cancer Recurrence For Subsequent Histologic Confirmation. Suspected Prostate Recurrence Is Based Upon Elevated Blood Prostate Specific Antigen (Psa) Levels Following Initial Therapy. In Clinical Studies, Images Were Produced With Pet/ct Coregistration. Limitation Of U Se: 11 C-Choline Pet Imaging Is Not A Replacement For Histologic Verification Of Recurrent Prostate Cancer. Choline C 11 Injection Is A Radioactive Diagnostic Agent For Positron Emission Tomography (Pet) Imaging Of Patients With Suspected Prostate Cancer Recurrence And Non-Informative Bone Scintigraphy, Computerized Tomography (Ct) Or Magnetic Resonance Imaging. In These Patients, 11 C-Choline Pet Imaging May Help Identify Potential Sites Of Prostate Cancer Recurrence For Subsequent Histologic Confirmation. Suspected Prostate Recurrence Is Based Upon Elevated Blood Prostate Specific Antigen (Psa) Levels Following Initial Therapy. In Clinical Studies, Images Were Produced With Pet/ct Coregistration. Limitation Of U Se: 11 C-Choline Pet Imaging Is Not A Replacement For Histologic Verification Of Recurrent Prostate Cancer ( 1 ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Choline C-11 CHOLINE C-11 ZINC3079337

Comments