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    Home > Medical News > Medical Research Articles > CDE drug review weekly report (2015.1.4-1.10)

    CDE drug review weekly report (2015.1.4-1.10)

    • Last Update: 2015-01-12
    • Source: Internet
    • Author: User
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    Among the 100 drugs approved to enter the approval process this week, only 29 are chemical drugs, and the rest are traditional Chinese medicine Among the 29 chemicals, 8 are imported, 2 are of 1.1, 8 are of 3.1, 2 are of 3.2, and 9 are of 6 categories The details are as follows: Table 1 was awarded the title of "orphan drug" by FDA in the original research of perreotide for injection, which was listed in the United States in December 2012 The dosage form is injection This product is a growth hormone inhibitor analogue It can inhibit the release of ACTH by binding with its receptor, so as to reduce the secretion of cortisol It is used to treat patients with Cushing's disease who cannot be treated by surgery At present, there are two imported declaration products in China, one of which obtained the clinical approval document in 2008, and the other was Novartis, which has obtained the clinical approval document as early as 2012 This approval is the new clinical application of Novartis in 2013 In addition, Novartis made a new clinical application at the end of 2014 Table 2 the new chemical medicine anestrol injection approved in Table 2 is presumed to be androsterol, which is used to protect neurons It was declared in April 2013 as a special approved variety In May 2014, it experienced a supplement of pharmacological and toxicological data At present, the approval has been completed, pending approval and certification, and the approval is still not approved It will be introduced later Epstein mesylate was successfully developed by SKB in 1997 It was listed in Germany in 1998 with the trade name of teveten Later, it was listed in the United States in 1999 At present, only imported products are listed in China Qingdao University of science and technology applied for the first time in China and obtained clinical approval in 2004 Chongqing Shenghua Xi pharmaceutical Co., Ltd was declared on May 3 + 6, 2012 It is the second enterprise in China to declare epsilon mesylate It is now in the approval stage In addition, Shandong innovative drug research and Development Co., Ltd has applied for iprisartan mesylate hydrochlorothiazide tablets in category 3.2, and the review is now nearing the end At present, pioglitazone metformin sustained-release tablets are not listed in China Jiangsu Haosen Pharmaceutical Co., Ltd once applied in 2010, but it was cheated In July 2012, it applied for the second time The result is unknown Table 3 in the approval of the chemical generic drug flupentine maleate is a new analgesic, its mechanism is a selective potassium channel opener, with analgesic, muscle relaxation and neuroprotection triple effects At present, there is only one import listed company in China, 14 companies apply for the listing of flupentine maleate capsules (another company name is unknown), and 3 companies apply for the clinical application of flupentine maleate sustained-release tablets 2 of the 56 approved drugs, 43 chemical drugs, 1 Traditional Chinese medicine, 6 biological products for treatment and 6 biological products for prevention The specific information of chemical drugs is as follows: of the 43 chemical drugs, 3 are imported, involving 2 varieties: Budesonide enteric coated capsules of Shenzhen kangzhe Pharmaceutical Co., Ltd and fexorubine fumarate sustained-release tablets of Pfizer (2 acceptance numbers) Table 4: after the approval of new chemical drug, propofol sodium for injection is jointly developed by Yichang humanwell and West China Hospital of Sichuan University It is a water-soluble propofol prodrug, and also the most advanced short-term general intravenous anesthetic in foreign research, with fast onset and recovery The acceptance number of this change in status was declared by humanwell at the end of 2013, and the acceptance number was the approval document of the third phase clinical trial If it is approved this time, humanwell is expected to receive three clinical approvals before the first quarter of next year For details of CM082 tablets of kananji Pharmaceutical Technology (Shanghai) Co., Ltd., please refer to the 20th issue of the weekly report
    The new compound preparation ticarcillin sodium and Sulbactam Sodium for injection declared by Haikou kangliyuan Pharmaceutical Co., Ltd in category 1.5 has been inconclusive since 2004 There was a supplement for this product in 2012, and it was shown on January 8, 2015 that the preparation and certification were completed However, today, it's back to the review This twists and turns is really elusive There are so many problems left over from history The state change is as follows: Figure 1 state change of ticarcillin sodium and Sulbactam Sodium for injection table 5 approved generic drugs The bioequivalence test of clopidogrel bisulfate tablets of Henan Tianfang Pharmaceutical Co., Ltd was approved; the announcement of disapproval of fudosten tablets of Shandong Luoxin Pharmaceutical Co., Ltd was made; the bioequivalence test of pramipexole hydrochloride tablets of Huayu (Wuxi) Pharmaceutical Co., Ltd was also approved These three generic drugs took more than four years from acceptance to approval Once again, it took a long time There are 48 chemicals, 1 6 kinds of traditional Chinese medicine, 16 biological products for treatment, 3 biological products for prevention and 1 in vitro diagnostic reagent Table 6: imported chemical drugs after the completion of certification table 7: the new chemical drugs of Shenzhen micro core Biotechnology Co., Ltd after the completion of certification, xidaban amine has finally been prepared The manufacturer should have obtained the production approval, which is only one step away from the hospital Finally, the indication of cedarbendamine was confirmed and used to treat recurrent or refractory peripheral T-cell lymphoma At present, the CDE clinical trial registration and information release platform shows that the product is still in the phase II clinical trial of advanced non-small cell lung cancer, and is being recruited Table 8: most of the generic drugs after the completion of the certification are amino acid salt APIs Most of these raw materials are components of compound ketoacid tablets At present, there are 5 or 6 domestic listed generic drugs.
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