FDA Approved QIDP and FTD of XNW4107
January 15, 2021, FDA approved QIDP (qualified infectious drug product) and FTD (fast track design) of XNW4107, a new generation β- The lactamase inhibitor (BLI) of Sinovent for two indications of cUTI (complex urinary tract infection) and HABP/VABP (hospital or ventilator-acquired pneumonia).
QIDP is a new drug special approval channel produced by the GAIN (Generating Antibiotic Incentives Now) Aact under the FDA safety and innovation act in July 2012, which aims to stimulate the research and development of antibiotics to deal with the serious life-threatening bacterial infection.
FTD aims to accelerate drug development and rapid review for serious diseases to address serious unmet medical needs in key areas. The FTD qualification means that pharmaceutical companies can interact with FDA more frequently in the R & D stage. After submitting the listing application, if met the relevant standards, they are eligible for accelerated approval and priority review.