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

Xiang Lei; Jing Chen; Chun-Xiang Liu; Jia Lin; Jing Lou; Hong-cai Shang

doi:10.1007/s11655-014-1936-0

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

OriginalPaper | Updated：2021-08-27

- Status and thoughts of Chinese patent medicines seeking approval in the US market
- Status and thoughts of Chinese patent medicines seeking approval in the US market
- 中国结合医学杂志（英文版） 2014年20卷第6期页码：403-408
- Affiliations：
  
  1. Tianjin University of Traditional Chinese Medicine,Tianjin,China
  2. Tianjin Institute of Clinical Evaluation of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine,Tianjin,China
- Author bio：
- Funds：
  
  Supported by Natural Science Foundation of China (No. 81273935)
- DOI：10.1007/s11655-014-1936-0
  中图分类号：
- 纸质出版日期：2014，
  
  网络出版日期：2014-6-21，
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Lei, X., Chen, J., Liu, CX. et al. Status and thoughts of Chinese patent medicines seeking approval in the US market., Chin. J. Integr. Med. 20, 403–408 (2014). https://doi.org/10.1007/s11655-014-1936-0

Xiang Lei, Jing Chen, Chun-Xiang Liu, et al. Status and thoughts of Chinese patent medicines seeking approval in the US market[J]. Chinese Journal of Integrative Medicine, 2014,20(6):403-408.
Lei, X., Chen, J., Liu, CX. et al. Status and thoughts of Chinese patent medicines seeking approval in the US market., Chin. J. Integr. Med. 20, 403–408 (2014). https://doi.org/10.1007/s11655-014-1936-0 DOI：

Xiang Lei, Jing Chen, Chun-Xiang Liu, et al. Status and thoughts of Chinese patent medicines seeking approval in the US market[J]. Chinese Journal of Integrative Medicine, 2014,20(6):403-408. DOI： 10.1007/s11655-014-1936-0.

摘要

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.

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 (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)

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.

关键词

Chinese MedicineBotanical DrugFood and Drug Administration’s review

Keywords

Chinese MedicineBotanical DrugFood and Drug Administration’s review

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