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资料来源:FDA网站发布时间:2011.02 04美国食品药品监督管理局(FDA)今日审批通过了Makena(已酸羟孕酮)注射剂,这种药物用于有过自发性流产经历的怀有单胎的孕妇,该药物可以减少怀孕37周前的流产风险。FDA是按照相关部门的快速审批流程规定审批通过Makena,这种快速审批流程允许基于可以合理预测临床疗效的代表性效果对药物进行审批(这里是依据减少怀孕37周前流产风险的疗效)。在这一审批流程下,药品生产厂商必须在产品通过审批后进行附加的研究,这种附加的研究要能够证明这种药品确实具有临床疗效。一项国际实验研究正在进行,这项实验研究Makena是否能够改善生育质量。这里的生育质量包括减少死胎或是病胎的数量。
Source: FDA Web site Release Date: 2011.02 04 The U.S. Food and Drug Administration (FDA) approved today the Makena (oxycodone) injection, which is used in single-child, spontaneous abortions Pregnant women, the drug can reduce the risk of miscarriage 37 weeks before pregnancy. The FDA approves Makena's approval process in accordance with the relevant department's Rapid Approval Process, a rapid approval process that allows for the approval of drugs based on a representative effect that can reasonably predict clinical efficacy, based on the efficacy of reducing the risk of miscarriage at 37 weeks of gestation. Under this approval process, drug manufacturers must conduct additional studies after product approval, an additional study that can demonstrate that the drug does have a clinical benefit. An international experimental study is underway to examine whether Makena can improve fertility. The quality of childbirth here includes reducing the number of stillbirths or sick fetuses.