Zoetis Statement on Withdrawal of Marketing Authorizations for 3-Nitro® and Carb-O-Sep®
FLORHAM PARK, N.J., October 1, 2013 – Zoetis Inc., (NYSE: ZTS) formerly the animal health business unit of Pfizer Inc., has notified the U.S. 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 U.S.sales of this product, on July 8, 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 authorization 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 authorization for this product.
Zoetis (zō-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on a 60-year history as the animal health business of Pfizer, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines complemented by diagnostic products and genetic tests and supported by technical services, with a focus on both farm and companion animals. In 2012, the company generated annual revenues of $4.3 billion. With approximately 9,300 employees worldwide at the beginning of 2013, Zoetis has a local presence in approximately 70 countries, including 29 manufacturing facilities in 11 countries. Its products serve veterinarians, livestock producers and people who raise and care for farm and companion animals in 120 countries. For more information on the company, visit www.zoetis.com.