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

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• 作者：Xiang Lei (1) (2)
  Jing Chen (1)
  Chun-Xiang Liu (1) (2)
  Jia Lin (1) (2)
  Jing Lou (1) (2)
  Hong-cai Shang (1) (2)
  
• 关键词：Chinese medicine ; botanical drug ; Food and Drug Administration’s review
• 刊名：Chinese Journal of Integrative Medicine
• 出版年：2014
• 出版时间：June 2014
• 年：2014
• 卷：20
• 期：6
• 页码：403-408
• 全文大小：191 KB
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• 作者单位：Xiang Lei (1) (2)
  Jing Chen (1)
  Chun-Xiang Liu (1) (2)
  Jia Lin (1) (2)
  Jing Lou (1) (2)
  Hong-cai Shang (1) (2)
  
  1. Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
  2. Tianjin Institute of Clinical Evaluation of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
  
• ISSN：1993-0402

文摘

Veregenand 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.