2004年6月，F(xiàn)DA正式發(fā)布《植物藥產(chǎn)品指南》，使植物藥以藥品形式在美國上市成為可能。到目前為止，F(xiàn)DA只批準(zhǔn)了Veregen和Fulyzaq兩例植物藥，F(xiàn)ulyzaq是FDA批準(zhǔn)的第2例植物藥，是第1例口服植物藥制劑。Fulyzaq的批準(zhǔn)是FDA對植物藥的再次放行，針對Fulyzaq的基本情況、研發(fā)及審批歷程以及臨床研究情況進行了介紹，并對此進行了分析，提出了一些建議，以期為中藥的研發(fā)和注冊提供參考。

“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.