Radiation Emergencies

Leukine (sargramostim (solution) injection and sargramostim (lyophilized powder) for injection)

• FDA approves Leukine for Acute Radiation Syndrome

Neulasta (pegfilgrastim) injection

Neupogen (filgrastim) injection

• FDA approves radiation medical countermeasure

Nypozi (filgrastim-txid; FDA approved 6/26/2024)

Pentetate calcium trisodium (Calcium-DTPA) injection and pentetate zinc trisodium (Zinc-DTPA) injection

• FDA Approves Drugs to Treat Internal Contamination from Radioactive Elements
• Questions and Answers on Calcium-DTPA and Zinc-DTPA

Potassium Iodide (KI) tablets and oral solution

• Frequently Asked Questions on Potassium Iodide (KI)
• KI in Radiation Emergencies-Questions and Answers quidance for Industry (2002) 
• Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies Guidance (2001)
• FDA Talk Paper: Guidance on Protection of Children and Adults Against Thyroid Cancer in Case of Nuclear Accident
• Position statement from the American Academy of Allergy, Asthma, and Immunology: The Risk of Severe Allergic Reactions from the Use of Potassium Iodide for Radiation Emergencies
• Potassium Iodide (KI):  Instructions to Make KI Solution for Use During a Nuclear Emergency (Liquid Form) including palatability and stability information
• Potassium Iodide Tablets: Shelf Life Extension Guidance for Federal Agencies and State and Local Governments (2004) 

Radiogardase (Prussian blue insoluble) capsules

• FDA approves the first New Drug Application for treatment of radiation contamination
• Questions and Answers on Prussian Blue (FDA Archive)

Ziextenzo (pegfilgrastim-bmez; FDA approved 2/28/2024)

Product Development Guidance

• Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
• FDA News:  FDA Encourages New Applications for Drugs to Treat Internal Contamination from Radioactive Elements (2003)
• Internal Radioactive Contamination - Development of Decorporation Agents Guidance for Industry (2006)
• Calcium DTPA and Zinc DTPA Drug Products – Submitting a New Drug Application Guidance for Industry (2004)
• Prussian Blue Drug Products—Submitting a New Drug Application Guidance for Industry (2003)
• FDA encourages New Drug Application submissions for Prussian blue as a treatment for thallium or radioactive cesium contamination (2003)

Additional Information

• See U.S. Department of Health & Human Services Radiation Emergency Medical Management for additional information.
• Radiological and Nuclear Emergency Preparedness Information from FDA
• Radiation Safety
• Radiation Emergencies (Centers for Disease Control and Prevention)