Medicatedfeed.Com Website Medicatedfeed Updates Manufacturer Drug Labels · Manufacturer Labels Zilpaterol Zilmax 2015-12

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Medicatedfeed.Com Website Medicatedfeed Updates Manufacturer Drug Labels · Manufacturer Labels Zilpaterol Zilmax 2015-12

medicatedfeed.com newsletter january 2016 Topics Updates to medicatedfeed.com website medicatedfeed Updates Manufacturer Drug Labels · Manufacturer Labels Zilpaterol Zilmax 2015-12. Merck Animal Health has issued an updated label for their · Drug Clearances Zilmax (zilpaterol hydrochloride) product. FDA News Drug Clearances · Drug Approval Withdrawals With the withdrawal of nitarsone, the status of the clearances associated with nitarsone · Nitarsone were changed to Withdrawn in the medicatedfeed database. One can still view the clear- Withdrawal ances, however, with the knowledge that they are no longer active. FDA Update—Withdrawal of Drug Approvals Major dairy goat breeds in the US Alpine LaMancha Nubian Saanen Toggenburg Oberhasli medicatedfeed.com 19613 301st Ave Belle Plaine, MN 56011 Phone: 952-873-9338 Email: medicatedfeed@frontier .com medicatedfeed.com - Your Online Resource to Drug Clearances and Labeling FDA Notes & News FDA Announces Pending Withdrawal of Approval of Nitarsone UPDATED December 17, 2015: The approval of all applications for use of nitarsone in animal feed is withdrawn as of December 31, 2015. Following this action, there are no FDA- approved, arsenic-based drugs for use in food producing animals. tional studies that affirm the findings of its 2011 roxarsone study. FDA Correspondence from April, 2015 Ownership of the roxarsone application subsequently changed The U.S. Food and Drug Administration today announced to Zoetis, which continued the suspension from sale of 3- Ni- that it has received a letter of commitment from Zoetis Ani- tro and ultimately withdrew the new animal drug application mal Health that, by the fall of 2015, the company will suspend for that drug on February 27, 2014. On the same day, Zoetis sale of Histostat (nitarsone) and formally request that the and Huvepharma AD voluntarily withdrew all new animal drug FDA withdraw the approval for the drug by the end of 2015. approvals and supplements for roxarsone, as well as two other Nitarsone is the only arsenic-based animal drug that is cur- arsenical new animal drugs, arsanilic acid and carbarsone. rently approved for use in food animals. Nitarsone is ap- Zoetis holds three approved animal drug applications for nitar- proved for the prevention of blackhead disease sone: Histostat-50 (approved for use in chickens and turkeys (histomoniasis) in turkeys and chickens, but is predominantly for prevention of blackhead); and two combination use approv- used in turkeys. als, BMD/Histostat and Albac/Histostat (approved for use in Arsenic is in the environment as a naturally occurring sub- turkeys for prevention of blackhead). All three uses would stance or as a contaminant and is found in water, air, soil, and cease to be marketed upon withdrawal of the nitarsone ap- food. Published scientific reports have indicated that organic proval. arsenic, the less toxic form of arsenic present in the arsenic- Blackhead is a disease that occurs seasonally in certain parts of based animal drugs, could transform into inorganic arsenic, a the country and is a cause of significant mortality in turkeys. known carcinogen. Currently, nitarsone is the only animal drug approved for man- In 2011, Alpharma, then the sponsor of 3-Nitro (roxarsone), aging this disease in turkeys. Under the phase-out plan being suspended marketing of that drug after an FDA study meas- announced today, nitarsone will continue to be available for the ured higher levels of inorganic arsenic were present in the 2015 season. This strategy allows affected producers the op- livers of chickens fed roxarsone, compared to those of un- portunity to consider alternatives for managing this disease in treated control chickens. The FDA has since completed addi- the future. .

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Advances in Interference Removal for Accurate Arsenic Analysis in Food
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