Fluciclovine F-18

FDA Drug Profile — Axumin

Drug Details

Generic Name
Fluciclovine F-18
Brand Names
Axumin
Application Number
NDA208054
Sponsor
Blue Earth Diagnostics
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
FLUCICLOVINE F-18

Indications and Usage

1 INDICATIONS AND USAGE Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment ( 1 ).