Guidance for Industry on Pentetate Calcium Trisodium and Pentetate Zinc Trisodium for Treatment of Internal Contamination with Plutonium, Americium, or Curium; Availability

摘要

The Food and Drug Administration (FDA) is announcing that we (FDA) have concluded that pentetate calcium trisodium (Ca-DTPA) and pentetate zinc trisodium (Zn-DTPA), when produced under conditions specified in approved new drug applications (NDAs), can be found to be safe and effective for the treatment of internal contamination with plutonium, americium, or curium to increase the rates of elimination. We encourage the submission of NDAs for Ca-DTPA and Zn- DTPA drug products. We are also announcing the availability of a guidance for industry entitled "Calcium-DTPA and Zinc-DTPA Drug Products--Submitting a New Drug Application." This guidance is intended to assist manufacturers who plan to submit NDAs for Ca-DTPA and Zn-DTPA.