2004年6月，FDA正式发布《植物药产品指南》，使植物药以药品形式在美国上市成为可能。到目前为止，FDA只批准了Veregen和Fulyzaq两例植物药，Fulyzaq是FDA批准的第2例植物药，是第1例口服植物药制剂。Fulyzaq的批准是FDA对植物药的再次放行，针对Fulyzaq的基本情况、研发及审批历程以及临床研究情况进行了介绍，并对此进行了分析，提出了一些建议，以期为中药的研发和注册提供参考。

“Guidance for Industry: Botanical Drug Products” was issued in June, 2004, which means it is possible for the botanical product as a real drug market in USA. But so far, FDA has approved only two cases of botanical drugs, Veregen and Fulyzaq. Fulyzaq is the second case of botanical drug, but the first oral botanical drug approved by FDA. The approval of Fulyzaq is an allowance on the botanical product. In this paper, the development approval history and clinical research of Fulyzaq are introduced and analyzed, and some suggestions are put forward, so as to provide the references for the development and registration of Chinese materia medica.