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口服型新兽药;撤销已批准的新兽药申请;土霉素(Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Oxytetracycline)

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放大字体  缩小字体 2014-12-23 02:43:07  来源:美国联邦公报  浏览次数:458
核心提示:美国FDA发布一则新兽药批准撤销的通知。撤销已批准的畜禽含药饮用水所用的土霉素可溶性粉的简式新兽药申请。原因是此项产品将不再生产和销售。
发布单位
美国FDA
美国FDA
发布文号 暂无
发布日期 2014-12-15 生效日期 暂无
有效性状态 废止日期 暂无
备注  美国FDA发布一则新兽药批准撤销的通知。撤销已批准的畜禽含药饮用水所用的土霉素可溶性粉的简式新兽药申请。原因是此项产品将不再生产和销售。

  ACTION

  Notification Of Withdrawal Of Approval.

  SUMMARY

  The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) for an oxytetracycline soluble powder used to make medicated drinking water for livestock and poultry. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed.

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  DATES:

  FOR FURTHER INFORMATION CONTACT:

  SUPPLEMENTARY INFORMATION:

  DATES:

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  Withdrawal of approval is effective December 26, 2014.

  FOR FURTHER INFORMATION CONTACT:

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  Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9075, sujaya.dessai@fda.hhs.gov.

  SUPPLEMENTARY INFORMATION:

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  Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 has requested that FDA withdraw approval of ANADA 200-305 for Oxytetracycline Hydrochloride Soluble Powder because the product is no longer manufactured or marketed. Note this ANADA was identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209”, December 2013.

  Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of ANADA 200-305, and all supplements and amendments thereto, is hereby withdrawn, effective December 26, 2014.

  Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of this application.

  Dated: December 9, 2014.

  Bernadette Dunham,

  Director, Center for Veterinary Medicine.

  [FR Doc. 2014-29248 Filed 12-12-14; 8:45 am]

  BILLING CODE 4164-01-P

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