Status and thoughts of Chinese patent medicines seeking approval in the US market

Veregen (TM) and Fulyzaq are the first two botanical drug products that were approved by the Food and Drug Administration (FDA) to market in the US in recent years. Additional herbal medicines, including Compound Danshen Dripping Pills (acurrency signiae-(1)a(1)a,ae >>' a), Fuzheng Huayu Tablets (ae parts per thousand ae aOE-c pound similar to Euroc parts per thousand double dagger), Xuezhikang Capsule (eEuro e,a(0)center dot e integral a > S), Guizhi Fuling Capsule (ae,aeeeOE-e S), Kanglaite Capsule (a(0)center dot eZ +/- c parts per thousand(1)e integral a > S) and Kanglaite Injection (a(0)center dot eZ +/- c parts per thousand(1)ae(3)a degreesae (2)), have filed the investigational new drug (IND) application to the FDA and are in phase II or phase III clinical development. In order to gain better understanding of the process of botanical drug approval in the US, this article examines the aforementioned drugs by looking at their composition, indication, prior clinical experience and clinical development process, and summarizes key features that enabled IND filing and marketing approval by the FDA.