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    Home > Active Ingredient News > Drugs Articles > The first variety that passed the consistency evaluation was born: tenofovir fumarate dipivoxil tablets

    The first variety that passed the consistency evaluation was born: tenofovir fumarate dipivoxil tablets

    • Last Update: 2017-12-06
    • Source: Internet
    • Author: User
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    Source: magic cube data 2017-12-06 China biopharmaceutical Co., Ltd announced on December 5 that the drug "tenofovir dipivoxil fumarate tablets" developed by the group has obtained the drug registration approval issued by CFDA for the treatment of chronic hepatitis B In the announcement, China biopharmaceutical specially pointed out that this product is the first one in China to complete the bioequivalence research according to the "evaluation of quality and efficacy consistency of generic drugs", and to conduct head-to-head clinical trials with the original research drug The group became the first enterprise to pass the consistency evaluation Zhengda Tianqing submitted the application for registration of "tenofovir dipivoxil fumarate tablets" (acceptance No cyhs1600082) according to the classification of new chemicals The application was accepted by CDE on October 17, 2016, and was included in the priority review by CDE on December 2, 2016 for the reason of "AIDS drug" 2017 / 10 / 17 was approved, just a full year before the application was submitted Tenofovir dipivoxil fumarate is a first-line drug in the treatment of chronic hepatitis B Compared with lamivudine, adefovir and other nucleoside drugs, it has the advantages of stronger and faster antiviral effect, lower incidence of drug resistance and higher safety for pregnant women with grade B pregnancy
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