FDA批准上市获得QIDP认证的新药概况

摘要/Abstract

摘要： 目的了解FDA批准上市的QIDP认证的8种新抗菌药概况。方法查阅近年来国内外相关文献75篇,对其进行归纳、总结和分析。结果目前全球已上市8种QIDP认证的抗菌药,适用于治疗由耐药致病菌引起的严重感染,抗菌谱广,抗菌活性强,耐受性良好。结论 FDA批准上市的8种QIDP认证抗菌药在全球面临耐药菌的威胁下值得进一步研究。

关键词: QIDP认证, 达巴万星, 泰地唑胺磷酸酯, 奥利万星, 头孢他啶/阿维巴坦, 头孢洛扎/他唑巴坦, 硫酸艾莎康唑, 德拉沙星, 美罗培南/ vaborbactam

Abstract: ObjectiveTo overview the 8 new antibacterials with QIDP certification approved by the FDA. Methods The relevant 75 papers about 8 FDA approved QIDP antibacterial drugs were summarized and analyzed. Results At present, 8 antibacterial drugs with QIDP qualification have been marketed and are suitable for the treatment of serious infections caused by drug-resistant pathogens. They have the characteristics of broad antibacterial spectrum, strong antibacterial activity, and good tolerance. Conclusion Facing with the challenge of global drug resistance, the 8 antibacterial drugs with QIDP certification approved by the FDA are worthy of more research.

Key words: QIDP, dalbavancin, tedizolid phosphate, oritavancin, ceftolozane/tazobactam, ceftazidime/avibactam

中图分类号:

牛亚平, 梁蓓蓓, 孙湃, 王睿, 贾晋生. FDA批准上市获得QIDP认证的新药概况[J]. 中国药物警戒, 2018, 15(9): 564-571.

NIU Yaping, LIANG Beibei, SUN Pai, WANG Rui, JIA Jinsheng. Review of New Drugs with QIDP Certification Approved by FDA[J]. Chinese Journal of Pharmacovigilance, 2018, 15(9): 564-571.

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