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

Veregen™ 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 (复方丹参滴丸), Fuzheng Huayu Tablets (扶正化瘀片), Xuezhikang Capsule (血 脂康胶囊), Guizhi Fuling Capsule (桂枝茯苓胶囊), Kanglaite Capsule (康莱特胶囊) and Kanglaite Injection (康莱特注射液), 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.