Zuelacetan, an antiepileptic drug of Jingxin pharmaceutical, has obtained new drug certificate and registration approval

Zhejiang Jingxin pharmaceutical announced that the company and its wholly-owned subsidiary Shangyu Jingxin Pharmaceutical Co., Ltd received the new drug certificate (Certificate No.: gdzzh20140034) approved and issued by the State Food and drug administration At the same time, the company received the drug registration approval document of zuelacetan tablets (specifications of 0.25g and 0.5g) approved and issued by the State Food and drug administration The approval document numbers are gjzz h20143177 and gjzz h20143178 respectively The registration is classified as Category 6 of chemical drugs, and the approval document numbers are valid until June 5, 2019 Shangyu Jingxin Pharmaceutical Co., Ltd has received the drug registration approval document of zuelacetan API approved and issued by the State Food and Drug Administration with the approval number of 2014s00501, the registration classification of which is category 3.1 of chemical drugs, the drug approval number of which is gyzz h20140068, and the validity of which is until June 5, 2019 According to reports, levetiracetam is a new type of antiepileptic drug developed by UCB company of Belgium, which was approved by SFDA for import into China in November 2006 Compared with the same kind of drugs, levetiracetam has the advantages of high therapeutic index, can be used as a single treatment, can be used as a broad-spectrum antiepileptic treatment drug, and does not interact with other antiepileptic drugs, and has the unique performance of preventing epilepsy It has slight adverse reactions and good tolerance It is a representative of a new kind of antiepileptic drugs, and is currently the United States epilepsy treatment The most widely used new antiepileptic drugs in the field of epilepsy treatment have broad application prospects The company is one of the first batch of domestic manufacturers to obtain the approval for the production of levetiracetam APIs and tablets, and it is also the company's first product for the treatment of epilepsy Its approval further enriches the company's varieties of psychoneuroses Some industry research reports pointed out that the company has continued to invest in research and development in recent years, with rich product reserves Levetiracetam is expected to enter the hospital through the agent sales mode in the second half of the year In addition, the Alzheimer's drug kabaratin is expected to be approved within this year, the first impact of imitation.