CDE drug review weekly report (2015.3.16-3.22)

1 Among the 26 drugs approved to enter the approval process this week, 14 are chemical drugs, 4 are traditional Chinese medicine, 5 are biological products for treatment, 2 are biological products for prevention, and 1 is in vitro diagnostic reagent The specific drug information is as follows: weikagre of Jiangsu Weikeli Pharmaceutical Technology Co., Ltd introduced it last week The dp-vpa tablet of Jiangsu Enhua Pharmaceutical Co., Ltd comes from d-pharm company, and they signed an agreement Enhua pharmaceutical exclusively conducts clinical research, registration, production and sales of dp-vpa in the treatment of epilepsy patients in China Dp-vpa is a phospholipid derivative of valproate, which is used to treat epilepsy, migraine and bi-directional affective disorder It is well known that valproic acid is the first choice drug to treat epilepsy at present, but it has some side effects, which are easy to cause hepatotoxicity, pancreatitis, teratogenicity, thrombocytopenia and hyperammonemia Dp-vpa is an improved variety of valproate with better safety and pharmacokinetics Dp-vpa tablet entered the CDE queue in February 2014 It is a special approved variety and has not been issued or supplemented At present, the technical review has been completed and the clinical approval has been successfully obtained Omeprazole sodium bicarbonate has other names - compound omeprazole, tablets, dry suspension, capsules and so on Before and after 2010, a large number of enterprises declared that this product was shot by the State Administration, including imports However, this week's Xiamen Encheng Pharmaceutical Co., Ltd is a super lucky company In July 2013, it applied for the listing of omeprazole sodium bicarbonate capsule At present, the three in one review has been completed, and approval may be around the corner At present, the product is not listed in China, and Xiamen Encheng is likely to be the first enterprise to list the product in China At present, only one tablet and one injection of linezolid are imported and listed in China Jiangsu Haosen Pharmaceutical Co., Ltd has applied for the raw materials, injection and tablet of linezolid The raw materials and injection have been reviewed and are in the approval stage The biological equivalent effect of the tablet has been completed, waiting in line for review Whether it can successfully occupy the market of import enterprises depends on the final result 2 35 chemicals, 9 traditional Chinese medicines and 1 biological product for prevention are among the 45 drugs approved this week First of all, let's take a look at class 1 Chemicals: prochloraz tablets of Suzhou Kaifa Pharmaceutical Co., Ltd., bpi-9016m tablets of Beida Pharmaceutical Co., Ltd and lalotinib mesylate capsules of Guangdong dongyangguang For specific information, please refer to review weekly report No 27 (reply to weekly report catalog and click the link of No 27) See review weekly report No 28 for specific information of ibuprofen injection Dbpr108 capsule of Shiyao group is a new antidiabetic drug jointly developed with an enterprise in Taiwan It entered CDE in August 2013 and is a special approved variety It was supplemented in June 2014 and has been approved for clinical use Let's take a look at other approved drugs: the three types of drugs approved this week are clinical applications, almost all of which are approved for clinical use In addition, the two antiviral drugs declared by GSK and Gilead also obtained clinical approval 3 Of the 5 drugs that have been completed this week, 3 are chemicals, 1 is biological product for treatment, and 1 is biological product for prevention Chemical drugs are enmd-2076 and Abbott's enteral nutrition suspension (2 acceptance numbers) Enmd-2076 is an anti breast cancer drug, which has been approved twice in China in 2014, and this is the third time For more articles, please leave a message in the background, reply to the "catalogue of weekly newspapers" and view the previous weekly newspapers; Xianda pharmaceutical news is also open, and the reply time is like "201502" to view the second issue of 2015 Pharmaceutical News, and the approval monthly news is also online, reply to the "catalogue of approval documents" and view the published monthly news Welcome to read!