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 （复方丹参滴丸）, Fuzheng Huayu Tablets （扶正化瘀片）, Xuezhikang Capsule （血脂康胶囊...

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Published inChinese journal of integrative medicine Vol. 20; no. 6; pp. 403 - 408
Main Author 雷翔 陈静 刘春香 林佳 楼静 商洪才
Format Journal Article
LanguageEnglish
Published Heidelberg Chinese Association of Traditional and Western Medicine 01.06.2014
Subjects
China
Drug Approval - legislation & jurisprudence
Drugs, Chinese Herbal - therapeutic use
FDA
Feature Article
Humans
Medicine
Medicine & Public Health
Nonprescription Drugs - therapeutic use
United States
United States Food and Drug Administration
专利
中国
临床经验
复方丹参滴丸
开发过程
美国市场
药品
United States
China
Food and Drug Administration’s review
Chinese medicine
botanical drug
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Summary: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 （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 phaseⅡ 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.
Bibliography:11-4928/R
LEI Xiang , CHEN Jing , LIU Chun-Xiang, LIN Jia, LOU Jing ,SHANG Hong-cai（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）
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 （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 phaseⅡ 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.
Chinese medicine； botanical drug； Food and Drug Administration＇s review
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1672-0415
1993-0402
DOI:10.1007/s11655-014-1936-0