CDE drug review weekly report (2015.9.21-2015.9.25)

During the review this week (2015.9.21-2015.9.25), 93 drugs (based on the acceptance number) entered the review status, with the number almost the same as last week Most of them are chemical drugs, a total of 88 Among them, the most are category 3.1, 38 in total, 5 categories 3.2, 3 categories 3.4, 2 categories 5, 33 categories 6 and 6 imports In addition, there are 3 biological products for treatment and 1 Traditional Chinese medicine This week, there is no class 1.1 chemical medicine Class 3.1 drugs are all previously reported It seems that there are no new drugs recently In addition, the imported drugs are not particularly novel, so the small edition will not introduce more In the approval week, 14 drugs were in the approval status, 13 chemicals, including 1 class 1.1 and 5 class 3.1 The key points are as follows: 1 Carbofloxacin hydrochloride and glucose injection: This product is declared by Jiangsu Hengrui group 1.1 and belongs to the fourth generation quinolone antibiotics In 2004, it was approved for clinical application, and in 2009, it was put on the market Up to now, it has been approved, but the conclusion is not clear See Table 1 for chemicals under approval After the approval, 117 drugs were approved this week According to this, more than one hundred drugs were approved every week, and the squeezed drugs could be finished soon In this week's 117 drugs, the most are still chemicals, accounting for 107 Two 1.1 new drugs of Jiangsu Hengrui, shr3680 and shr6390, have been approved for clinical use In addition, berberine hydrochloride, a 1.6 new drug of Northeast Pharmaceutical Group, was also approved for clinical use in the treatment of glycolipid metabolism syndrome Ruishuvastatin calcium and its tablets of Shandong dyne marine biopharmaceutical Co., Ltd are undergoing a three in one audit, and they are also to be approved for production by visual inspection This product has been listed in more than 10 domestic markets However, due to the good market of statins, it can still take a share In addition, there have been 6 approved clinical trials of candesartan axetil amlodipine tablets and 4 approved clinical trials of telmisartan amlodipine capsules this week There are too many drugs approved this week Interested friends can use our database to view them This week, 87 drugs and 86 chemicals have been certified A small part of them are not approved According to the variety name, 72 drugs are still the reason In addition, losartan dimethylmeglumine (2 specifications) for injection, a new class 3.1 drug of Shandong Luoxin, has been approved for clinical use It is the first one in China This product is marketed in the United States by methadone, with specifications of 150mg and 115mg It is mainly used to prevent acute and delayed nausea and vomiting caused by chemotherapy This product is the precursor of oral arepidem preparation, which is rapidly transformed into arepidem in vivo after injection Attached