What are the registration applications withdrawn on 3 17 in the self-examination of clinical trial data?

Announcement of China Food and Drug Administration on Self-inspection and Verification of Clinical Trial Data of Revoked Drugs (No.20 1, 20 15)

20 1510 June15

After the announcement of self-inspection of drug clinical trial data (China Food and Drug Administration AnnouncementNo. 169, No.20 15) was issued, 18 drug registration applications were withdrawn. The relevant information is hereby announced as follows:

1. There is no 169 of 20 15 in the announcement, and there are eight different opinions on withdrawing the registration application. Rupatadine fumarate tablets (acceptance number: CXHS0900004), rupatadine fumarate capsules (acceptance number: cxhs090005), memantine hydrochloride oral solution (acceptance number: cxhs100019), azerotipine capsules (acceptance number: cxhs19)

Cao Jin Zhike Oral Liquid (acceptance number: CXZS0800072) and recombinant anti-tumor necrosis factor-α human-mouse chimeric monoclonal antibody for injection (acceptance number: cxss 1200005) reached an agreement, submitted a description of the situation, and requested to keep the registration application of related varieties.

2. Not after the announcement. In 169 20 15 years, 12, the relevant applicants for drug registration voluntarily applied for withdrawal, that is, the non-butasai tablets declared by Unakang Ou Yi Pharmaceutical Co., Ltd. (acceptance number: CXHS 1300 166, cxhs/kloc-0 Furen Pharmaceutical Group Co., Ltd. declared simvastatin tablets (acceptance number: CYHS 1290 123), dexibuprofen dispersible tablets (acceptance number: CXHS0800093), adefovir dipivoxil dispersible tablets (acceptance number: CXHS 1400296) and roxithromycin ambroxol dispersible tablets (acceptance number: 0/400296). Diammonium glycyrrhizinate capsules (acceptance number: ibuprofen sustained-release capsules declared by Shaanxi Dongtai Pharmaceutical Co., Ltd. (acceptance number: CYHS 1290 129) and levonorgestrel tablets (acceptance number: CYHS 669) China Food and Drug Administration will apply for deregistration without verification and investigation.

It is hereby announced.

General administration of food and drug administration

20 1510 June15

Announcement of China Food and Drug Administration on Withdrawal of Registration Applications of Eight Enterprises, including Guangdong Baike Pharmaceutical Co., Ltd. (No.2015)

20 15 1 1.06

After the release of Announcement on Self-inspection and Verification of Drug Clinical Trial Data (Announcement No.20 15 of China Food and Drug Administration No.20 1 0), our bureau received 8 applications for withdrawal of drug registration from Guangdong Baike Pharmaceutical Co., Ltd., and the relevant information is hereby announced as follows:

The application for drug registration 10 was withdrawn: torasemide dispersible tablets declared by Guangdong Baike Pharmaceutical Co., Ltd. (acceptance number: CXHS 1200 148) and potassium sodium citrate tablets declared by Hainan Shuangcheng Pharmaceutical Co., Ltd. (acceptance number: cxhs1200148) Tolvaptan tablets declared by jiangsu hengrui Pharmaceutical Co., Ltd. (acceptance numbers: CXHS 1500064 and CXHS 1500065), fluoxetine hydrochloride capsules declared by Jiangsu Suzhong Pharmaceutical Group Co., Ltd. (acceptance number: cyhs1kloc-0/9065438), Nanjing Xingyin Pharmaceutical Co., Ltd. declared calcium dobesilate capsules (acceptance number: cyhs 1290065448Xi Anlijun Fiona Fang Pharmaceutical Co., Ltd. declared amlodipine besylate tablets (acceptance number: CYHS 1290040) and Xi Andetian Pharmaceutical Co., Ltd. declared diclofenac sodium sustained-release capsules (acceptance number: CYHS10)

It is hereby announced.

You can find detailed information on the website of the State Administration of Medical Products.

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