Drugs
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Calcium-DTPA and Zinc-DTPA Information Page
FDA has approved pentetate calcium trisodium injection (Calcium-DTPA) and pentetate zinc trisodium injection (Zinc-DTPA) for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.
- FDA Approves Drugs to Treat Internal Contamination from Radioactive Elements (FDA press release)
- Questions and Answers on Calcium-DTPA and Zinc-DTPA
- Approval Letter (PDF - 28KB)
- Pentetate Calcium Trisodium Injection Labeling
- Pentetate Zinc Trisodium Injection Labeling
- FDA Encourages New Applications for Drugs to Treat Internal Contamination from Radioactive Elements (FDA Press Release)
- Guidance for Industry: Calcium DTPA and Zinc DTPA Drug Products - Submitting a New Drug Application (PDF - 157KB)
- Federal Register Notice: Guidance for Industry on Pentetate Calcium Trisodium and Pentetate Zinc Trisodium for Treatment of Internal Contamination with Plutonium, Americium, or Curium; Availability
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