Issue Date: February 4, 2003
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Prussian Blue Drug Products — Submitting a New Drug Application
This guidance is intended to assist manufacturers wishing to submit new drug applications (NDAs) for prussian blue drug products for the treatment of internal contamination with radioactive thallium, nonradioactive thallium, or radioactive cesium. The Federal Register notice announcing the availability of this guidances explains in detail the Agency’s findings regarding safety and effectiveness and includes a list of the literature on which it based those findings.
Download the Guidance Document
