title: Status and thoughts of Chinese patent medicines seeking approval in the US market.
abstract: 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, Fuzheng Huayu Tablets, Xuezhikang Capsule, Guizhi Fuling Capsule, Kanglaite Capsule and Kanglaite Injection, 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.
authors: Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.
authors: Xiang
authors: X
authors: Lei
authors: Jing
authors: J
authors: Chen
authors: Chun-Xiang
authors: CX
authors: Liu
authors: Jia
authors: J
authors: Lin
authors: Jing
authors: J
authors: Lou
authors: Hong-cai
authors: HC
authors: Shang
mesh_terms: D002681:China; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004365:Drugs, Chinese Herbal; D004366:Nonprescription Drugs