FDA宣布即将撤回硝苯胂酸批准证书（在2015年底）

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FDA AnnouncesPending Withdrawal of Approval of Nitarsone(硝苯胂酸)

April 1, 2015

The U.S. Food and Drug Administrationtoday announced that it has received a letter of commitment from Zoetis AnimalHealth that, by the fall of 2015, the company will suspend sale of Histostat(nitarsone)（硝苯沙胂） and formally request that the FDA withdraw theapproval for the drug by the end of 2015. Nitarsone is the only arsenic-based animaldrug that is currently approved for use in food animals. Nitarsone is approved for theprevention of blackhead disease (histomoniasis)in turkeys and chickens, but is predominantly used in turkeys.

Arsenic is in the environment as anaturally occurring substance or as a contaminant and is found in water, air,soil, and food. Published scientific reports have indicated that organic arsenic, the lesstoxic form of arsenic present in the arsenic-based animal drugs, couldtransform into inorganic arsenic, a known carcinogen.

In 2011, Alpharma, then the sponsor of 3-Nitro (roxarsone)(洛克沙胂), suspended marketing of that drug after an FDAstudy measured higher levels of inorganic arsenic were present in the livers ofchickens fed roxarsone, compared to those of untreated control chickens. The FDAhas since completed additional studies that affirm the findings of its 2011roxarsone study.

Ownership of the roxarsone applicationsubsequently changed to Zoetis, which continued the suspension from sale of 3- Nitro andultimately withdrew the new animal drug application for that drug on February27, 2014. On the sameday, Zoetis andHuvepharma AD voluntarily withdrew all new animal drug approvals andsupplements for roxarsone, as well as two other arsenical new animal drugs, arsanilicacid(对氨苯基胂酸)and carbarsone(对脲苯基胂酸).

Zoetis holds three approved animal drugapplications for nitarsone: Histostat-50 (approved for use in chickens andturkeys for prevention of blackhead); and two combination use approvals,BMD/Histostat and Albac/Histostat (approved for use in turkeys for preventionof blackhead). All three uses would cease to be marketed upon withdrawal of the nitarsoneapproval.

Blackhead is a disease that occurs seasonallyin certain parts of the country and is a cause of significant mortality inturkeys. Currently, nitarsone is the only animal drug approved for managingthis disease in turkeys. Under the phase-out plan being announced today, nitarsonewill continue to be available for the 2015 season. This strategy allows affectedproducers the opportunity to consider alternatives for managing this disease inthe future.

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选自wikipedia
Contemporary usage[edit]Arsanilic acid gained use as a feed additive for poultry and swine to promote growth and prevent or treat dysentery.[2][3][4] For poultry and swine, arsanilic acid was among four arsenical veterinary drugs, along with carbarsone, nitarsone, roxarsone, approved by the U.S. Food and Drug Administration (FDA).[18] In 2013, the FDA denied petitions by the Center for Food Safety and by the Institute for Agriculture and Trade Policy seeking revocation of approvals of the arsenical animal drugs, but the drugs' sponsors voluntarily requested the FDA to withdraw approvals of three, including arsanilic acid, leaving only nitarsone approved.[5] Arsanilic acid is still used in the laboratory, for instance in recent modification of nanoparticles.[6]

现在看来nitarsone也被撤市了，arsanilic drugs也不得不面临将不再在市场上销售的命运了！

Whats

路过。。。。。。。