本次修订申请由Pharmgate LLC公司提出。新条例批准含亚甲基水杨酸杆菌肽的A类药物性物品用于生产鸡、火鸡、野鸡、鹌鹑、肉牛B类与C类药物饲料。
部分原文报道如下:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.
原文链接:https://www.federalregister.gov/articles/2015/12/22/2015-32000/new-animal-drugs-for-use-in-animal-feeds-bacitracin-methylenedisalicylate