美国食品药品管理局(FDA)2011年2月4日批准己酸羟孕酮(商品名,Makena)注射液用于预防已有自发性早产史的妊娠女性不足37周妊娠发生早产的风险。该药物不适用于多胎妊娠的女性,如双胞胎妊娠,或致早产的其他风险因素。FDA通过加速审批程序批准了Makena,此程序允许FDA对严重或危及生命疾病的药品,在确切的治疗效益证据未全部收集到之前批准新药申请(NDA)。使用“替代”终点的新药申请,审批者通常要求申请者递交流行病学、治疗学、病理生理学、以及其他证据表明该临床研究结果可以构成可靠的基础依据,以判断药品可影响目标疾病状态。本次FDA根据能够合理预测药物临床 The U.S. Food and Drug Administration (FDA) approved February 4, 2011 that Makena (caproxyprogesterone caproate) (Makena) injection was used to prevent premature birth in 37-week-old pregnant women who had a history of spontaneous preterm birth. The drug is not suitable for women with multiple pregnancies, such as twin pregnancies, or other risk factors for preterm labor. The FDA approved Makena through an accelerated approval process that allows FDA to approve new drug applications (NDA) for drugs that are serious or life-threatening until the exact evidence of benefit has been collected. Applicants using a “surrogate” endpoint for new drug applications often require applicants to submit epidemiology, therapeutics, pathophysiology, and other evidence that the results of the clinical study can form a solid foundation upon which the drug can affect the target disease status. The FDA is based on a reasonable prediction of drug clinical