CDE drug review weekly report (April 13, 2015 to April 19, 2015)

The drugs that enter the approval process this week are chemicals The details are as follows: Daphne hydrobromide sustained-release tablets, raw materials + sustained-release tablets, category 3 + 3 declaration of Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd is the only manufacturer applying for production of this product in China But this week, only one acceptance number is being approved, and it's a preparation What about the raw materials? Xiaobian inquired other information and found that there are two acceptance numbers for this type of dosage form, among which the acceptance number approved this week should have been killed, and the preparation and raw materials of another acceptance number are still under review At present, it is to be verified on site, which should be further from production! Both capecitabine tablets of Zibo Wanjie Pharmaceutical Co., Ltd and olanzapine tablets of Shanghai Xinya pharmaceutical Minhang Co., Ltd are not approved for publicity Beijing Shiqiao biopharmaceutical Co., Ltd.'s carmustine raw materials and class 5 injections are jointly declared The injections have been shot dead in the early days It is estimated that the raw materials should be produced in batches at present, and the CFDA's final approval result is still needed Darinaparsin is a small molecule arsenic derived apoptosis inducer of malignant cells, which is used to treat a variety of blood and solid tumors It has been used in the second phase of clinical trials in the United States This product was originally developed by ziopharm oncology, and then authorized to solasia pharma In 2010, the indications of darinaparsin in the treatment of peripheral T-cell lymphoma were identified as orphan drugs In early 2015, solasia and Meiji Seika reached an agreement to jointly develop and sell darinaparsin (intravenous injection) in Japan This product is currently applied for clinical application for the first time in China It is a special approved product In 2013, it has undergone two supplements At present, the review is completed and it is pending approval Four drugs have been approved this week, all of which are chemical drugs: Potassium Aspartate Injection of Inner Mongolia Baiyi Pharmaceutical Co., Ltd at present, the three in one review has been completed, and the batch is about to be produced At present, there is only one injection of potassium aspartate on the market in China In addition, the manufacturers of the injection on the market also exclusively listed the tablets of this product However, according to Xianda database hospital medication, the sales volume of this product in recent years has not been found, so how to make profits from this product has to wait and see At present, the three in one evaluation of diammonium glycyrrhizinate enteric coated tablets of Fujian lifick Pharmaceutical Co., Ltd has been completed, and it is estimated that they will also be produced in batches At present, diammonium glycyrrhizinate has injections and capsules in China There are many manufacturers, most of which are injections and 7 capsules However, enteric coated tablets have not yet been produced by manufacturers According to the medication of Xianda database hospital, the sales volume of diammonium glycyrrhizinate capsule in 2014 is close to 100 million, which is much higher than that of the injection, so the market of oral medication is OK If enteric coated tablets are on the market, it's still a little bit promising Among the 26 drugs, 8 are chemical drugs, 15 are traditional Chinese medicine, 2 are biological products for treatment, and 1 is in vitro diagnostic reagent Chemical information is as follows: minodronate tablets of Hefei Xinfeng Technology Development Co., Ltd have been approved for clinical use The eye drops of sodium bromfenate from Shandong Lukang Chenxin Pharmaceutical Co., Ltd have also completed the three in one review At present, there is only one imported and listed eye drops of bromfenate sodium hydrate in China This product is mainly used for the treatment of inflammatory diseases of outer and anterior eyes The omeprazole sodium bicarbonate capsule of Xiamen en Cheng Pharmaceutical Co., Ltd which has been mentioned in previous issues will also be approved soon!