Zoetis Withdraws Marketing Authorisation for Two Arsenicals09 October 2013
US - Zoetis Inc. has notified the US Food and Drug Administration (FDA) that the company will voluntarily withdraw the marketing authorizations (New Animal Drug Applications) for 3-Nitro (roxarsone) and Carb-O-Sep® (carbarsone).
The decision to withdraw the marketing authorization for 3-Nitro, a feed medicine containing the organic arsenical roxarsone, follows the suspension of US sales of this product, on 8 July 2011.
Zoetis suspended sales at the request of the FDA-based on a study conducted by the Agency. The study used a new method of testing for very low levels of inorganic arsenic in poultry tissue. It suggested that the use of 3-Nitro resulted in extremely low residue levels of inorganic arsenic in the liver of treated chickens. This extremely low level was equivalent to the amount of inorganic arsenic found in an eight-ounce glass of drinking water. Zoetis no longer manufactures 3-Nitro and has decided to withdraw the marketing authorisation for this product.
Carb-O-Sep, another arsenical feed medicine, has not been manufactured or marketed for more than a decade. Therefore, Zoetis has decided to withdraw the marketing authorisation for this product.
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