Calcium-DTPA and Zinc-DTPA Information Page

FDA approves New Drug Applications for pentetate calcium trisodium injection (Calcium-DTPA) and pentetate zinc trisodium injection (Zinc-DTPA) to treat people internally contaminated with plutonium, americium, or curium.

• FDA Press Release (issued August 11, 2004)
• Questions and Answers on Calcium-DTPA and Zinc-DTPA (revised August 11, 2004)
• Approval Letter (August 11, 2004)
• Pentetate Calcium Trisodium Injection: Labeling Approved August 11, 2004
• Pentetate Zinc Trisodium Injection: Labeling Approved August 11, 2004
• Calcium-DTPA Draft Labeling  (revised August 11, 2004)
• Zinc-DTPA Draft Labeling  (revised August 11, 2004)
• Federal Register Notice [HTML] [PDF]
• Guidance for Industry: Calcium DTPA and Zinc DTPA Drug Products - Submitting a New Drug Application [Word] or [PDF] (August 13, 2004)
• FDA Press Release (issued September 12, 2003)
• Drug Preparedness and Response to Bioterrorism. This CDER Web page provides links to the most current information on drug therapy and vaccines, plus advice on purchasing and taking medication.