![]() Sodium Nitrite Injection and Sodium Thiosulfate Injection are approved to be used sequentially: Sodium Nitrite is injected first, followed immediately by Sodium Thiosulfate, for the treatment of acute cyanide poisoning that is judged to be life-threatening. Additionally, in 2012, FDA approved NDAs for Sodium Nitrite Injection and Sodium Thiosulfate Injection, which are marketed in separate packaging. In 2011, FDA approved a New Drug Application (NDA) for Nithiodote, a co-packaged Sodium Nitrite Injection and Sodium Thiosulfate Injection drug product, indicated for the treatment of acute cyanide poisoning that is judged to be life-threatening. This notification was published in the Federal Register on Novem( ).įDA is taking this action because there are now FDA-approved versions of these drug products on the market (Table 1). This is part of FDA’s on-going effort to ensure that all drugs marketed in the United States have the required FDA approval and are safe, effective, of good quality, and appropriately labeled. The FDA is notifying companies to cease manufacture or marketing of unapproved drug products containing sodium nitrite or sodium thiosulfate labeled for the treatment of known or suspected cyanide poisoning. ![]() 1) What action is FDA taking regarding unapproved drug products containing sodium nitrite or sodium thiosulfate labeled for the treatment of known or suspected cyanide poisoning?
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