CDE drug review weekly report (September 26, 2015 to October 7, 2015)

In the review this week (2015.9.26-2015.10.7), 15 drugs (calculated by acceptance number) entered the review status Among them, there are 11 chemicals, the most of which is 3.1, 7 in total In addition, there are 1 biological product for treatment, 2 biological products for prevention and 1 Traditional Chinese medicine This week, Jiangsu kefeiping Pharmaceutical Co., Ltd applied for vonolazan fumarate tablets (2 specifications), and Ruiyang Pharmaceutical Co., Ltd applied for paboxib capsules (3 specifications) In addition, as soon as the oral live attenuated polio vaccine of type I and type III in Tiantan, Beijing was applied for production, the Certification Center issued a notice of on-site inspection At present, it is to be checked on site Since the editor does not know biological products very well, a friend who knows can tell whether this situation is in line with the routine at the background In the approval process of this week, there are 11 drugs, all of which are chemical drugs, 4 of which are 3.1 categories They are omeprazole dry suspension and midazolam new tablets, all of which have been approved for clinical use In addition, there are four 6 kinds of drugs, including maprotiline hydrochloride tablets and fluvastatin sodium capsules Fluvastatin sodium capsule was undertaken by Shandong Luoxin in June 2012 At present, it ranks over 1400, has been reviewed and is in the state of approval Another enterprise has applied for this product, which was undertaken in September 2011 and reviewed last week, is still in the state of approval See Schedule 1 (excluding import re registration) for the approved drugs After approval, 172 drugs have been approved this week Except for one traditional Chinese medicine, the rest are chemicals Among them, 5 are 1.1, 16 are 3.1, 123 are 6, and 13 are imported Key drugs: 1 Bubramine Hydrochloride Spray: This product is declared by the 1.1 class of Tianjin Xin Chen Tai Fei Pharmaceutical Technology Co., Ltd., which was commissioned by CDE in May 2014 It belongs to special examination and approval variety In 2015, 8 menstrual cycle was once supplementation, and now it has been approved for clinical practice Luoamin is a new ibuprofen derivative The spray type may be used to relieve muscle tissue pain and osteoarthritis At present, the specific indications are not clear Let's see how the clinic works 2 Furetinib succinate capsule: This product is declared by Chongqing furchuang Pharmaceutical Research Co., Ltd in category 1.1, and undertaken by CDE in March 2015 It is a special approved variety and a major special variety, and has been successfully approved for clinical use The specific target and indications of the product were not found in the small edition According to the name, it is presumed to be an anti-tumor drug In addition, a number of class 3.1 drugs were approved for clinical use this week, including besifloxacin hydrochloride eye drops of Jiangsu Yabang Epson Pharmaceutical Co., Ltd., the first clinical approval in China, avimopan capsule of Jiangxi Qingfeng Pharmaceutical Co., Ltd., etc
For the 123 approved 6 categories of drugs, the drugs with the most acceptance numbers are L-amlodipine besylate tablets, a total of 13, involving 10 enterprises; the next is montelukast sodium chewing tablets, a total of 7, involving 4 enterprises; in addition, montelukast sodium granules and montelukast sodium tablets, a total of 3 acceptance numbers, involving 2 enterprises; cefdini granules also have 7 acceptance numbers approved Bi, involving 5 enterprises, in addition to 4 acceptance number of cefdinir dispersible tablets The wind of centralized evaluation has blown a lot of varieties The National Bureau is very fast There are no drugs that have been certified this week Schedule 1