Wuhan Jianmin 5 traditional Chinese medicine kaiyuning tablet has not been approved before the second application for production
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Last Update: 2014-12-12
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Source: Internet
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Author: User
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According to the public information of the State Food and Drug Administration (CFDA), the application for production of five kinds of traditional Chinese medicine kaiyuning tablets and its raw material, Hypericum perforatum total flavonoids, of Wuhan Jianmin Pharmaceutical Group Co., Ltd was accepted This is the second time the company has applied to CFDA since the drug was not approved in November last year Kaiyuning tablet is a new antidepressant The data showed that the therapeutic effect of Hypericum perforatum preparation on mild to moderate depression was similar to that of amitriptyline and fluoxetine, and it had better tolerance, less side effects and mild characteristics Wuhan Jianmin has completed the clinical research on the new drug since 2010 Kaiyuning and its API project have also been approved by the national "12th Five Year Plan" major new drug creation project In 2012, Wuhan Jianmin applied for the production of kaiyuning tablets to the drug regulatory department for the first time, and submitted supplementary information in January 2013 In November 2013, the review status of the drug changed to "certificate preparation completed - approval document issued in Beijing" The company has been verified that the drug has not been approved, but the reason is unknown
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