Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (9): 564-571.

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Review of New Drugs with QIDP Certification Approved by FDA

NIU Yaping1, LIANG Beibei2, SUN Pai2, WANG Rui2, JIA Jinsheng3*   

  1. 1Department of Pharmacy, Shanxi Medical University, Shanxi Taiyuan 030001, China;
    2Center of Medicine/Medical Devices Clinical Research, Chinese People's Liberation Army General Hospital, Beijing 100853, China;
    3Shanxi Medical University Affiliated Jinmei Group General Hospital, Shanxi Jincheng 048006, China
  • Received:2018-11-02 Revised:2018-11-02 Online:2018-09-20 Published:2018-11-02

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

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