2012年5月1日―7月31日,共有18种药物获得了美国食品药品管理局(FDA)的批准,其中6种为1类新分子实体(NME)药物,如用于治疗罕见遗传疾病——戈谢病的新药Elelyso,13年来FDA首款批准的减肥药Belviq,以及用于治疗膀胱过度活动症的新药Myrbetriq等。结合5―7月FDA批准的新药药品标签说明书要点,着重对批准的1类NME新药进行介绍,包括其结构式、适应症、剂量用法、注意事项、不良反应等。 From May 1 to July 31, 2012, a total of 18 drugs were approved by the U.S. Food and Drug Administration (FDA), six of which are category 1 new molecular entity (NME) drugs such as those used to treat rare genetic diseases - Elegyso, Gaucher’s new drug, Belviq, the FDA’s first approved weight loss drug for 13 years, and Myrbetriq, a new drug used to treat overactive bladder. Combining with the key points of labeling of new drugs approved by the FDA in May-July, we mainly introduce the approved Class 1 NME drugs, including their structure, indications, dosage usage, precautions, adverse reactions and so on.