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Article: US FDA calls on pharma for anti-radiation NDAs.
- Article from:
- Pharma Marketletter
- Article date:
- September 22, 2003
CopyrightCOPYRIGHT 2003 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The US Food and Drug Administration says it has determined conditions under which pentetate calcium trisodium (Ca-DTPA) and pentetate zinc trisodium (Zn-DTPA) are safe and effective in the treatment of certain kinds of radiation exposure, and that it is now urging manufacturers to use these findings to submit marketing applications for Ca-DTPA and Zn-DTPA products.
The agency says it has determined that, when produced under conditions specified in approved marketing applications, Ca-DTPA and Zn-DTPA can be safe and effective for the treatment of internal contamination with plutonium, americium or curium, by increasing the rate of elimination of these radioactive ...