CDE drug review weekly report (April 19, 2015 to April 25, 2015)

Among the 60 drugs that entered the review sequence this week, 56 were chemicals, including 37 new drugs, 15 generic drugs and 4 imported drugs
Attention: this week, the drug dotiravir sodium tablet of GlaxoSmithKline for the treatment of AIDS was applied for production This product was approved in January this year, and now it has been applied for production This week, the first clinical application for 2 drugs in category 3.1 of Qilu pharmaceutical was applied for: trogliptin succinate and its tablets and pabulib and its capsules In addition, Guangdong Yili Group Pharmaceutical Co., Ltd applied for afort tartrate The new dosage form of Luo, that is, alfredox tartrate powder inhalation capsule Trogliptin succinate is a DPP4 inhibitor, an oral drug for diabetes It was listed in Japan in March 2015, the first weekly oral antidiabetic drug on the market in the world Qilu pharmaceutical industry declared it in China in April, and it was very fast In addition, another drug, pabxiclib, is Pfizer's new anti breast cancer drug, palbociclib, which was approved by FDA in February 2015 Qilu has also declared it There is not much else to say Worship first 2 Two drugs that entered the examination and approval process this week: class 3.3 drugs declared by Hubei Hepu Pharmaceutical Co., Ltd., Lansoprazole for injection (cxhs1100187); generic cefpodoxime ester tablets (cyhs1000660) declared by Hainan Meida Pharmaceutical Co., Ltd At present, more than 10 Lansoprazole for injection have been listed in China It's not easy for this company to be listed in 3.3 category However, it's hard work and hard work The three in one review has been completed 3 of the 8 approved drugs, 7 are chemical drugs and 1 is traditional Chinese medicine The chemical drugs are as follows: the new midana tablet of Nanjing Huawei Pharmaceutical Technology Development Co., Ltd has been approved for clinical use At present, there are 2 domestic enterprises (1 domestic, 1 imported) that have obtained clinical approval In 2014, Huawei was approved as the third, not too late Among the 60 drugs completed this week, 27 chemical drugs, 17 traditional Chinese medicine, 11 biological products for treatment, 4 biological products for prevention and 1 diagnostic reagent The chemical drugs are as follows: hs-10220 and its capsules of Jiangsu Haosen Pharmaceutical Co., Ltd have all been approved for clinical use, and hs-10220 capsule is found to be a drug for ulcer treatment The strontium ranelate dry suspension of shandongfangming Pharmaceutical Group Co., Ltd has been approved as bioequivalence clinical approval, and ozagrel for injection, which has long been put on the death list by the State Administration, has undoubtedly been harmed.