FDA accepts new drug application for Zerbaxa, a Mercado-difada antibiotic

recently,Pharmaceutical(http://giant Merck and Co announced that the U.SFood andDrug(http://Administration of(
FDA(http://has accepted complementar
yof compound antibioticsproducts (http://Zerbaxa (http:// and granted priority examination of theof new drug(http:// and specify the target date of the Prescription Drug User Charge Sfa (PDUFA) as June 3, 2019this sNDA application for approval of Zerbaxa for use in adult patients to treat hospital acquired bacterial pneumonia (HABP) and ventilator-related bacterial pneumonia (VABP) caused by certain susceptible gram-negative bacteriaZerbaxa's supplementary application is also under review by the EuropeanMedicines(http://Authority (EMA)The submission of this sNDAis based on positive data from key Phase III clinical studies ASPECT-NP (NCT02070757)this study, a forward-looking, random, double-blind, multicenter, non-effects study, was conducted in 726 adult patients diagnosed with HABP or VABP for intravenous antibiotic treatment, and assessed the efficacy and safety of Zerbaxa relative to meropenem, a wide-spectrum injectable antibiotic that is widely used clinically to treat serious infectionsstudy, Zerbaxa administered at an experimental dose of 3g, Meropinan with 1g, 2 drugs were treated with intravenous infusion sin every 8 hours for 8-14 days, and for copper-green pseudomonas infection for 14 daysdata show that Zerbaxa achieved non-disadvantage compared to controlled drugs in terms of all-cause mortality and clinical cure rates on the 28th day of follow-up after treatmentDetails of the study will be published at the
http://of the medicalconference in the futureAbout Zerbaxa
Zerbaxa is a compound antibiotic product that is administered intravenously and consists of ceftolozane (cephalospora) and tazobactam,the former a new type of cephalosporin antibiotic and the latter a beta-lactamase inhibitor 　　Zerbaxa was originally developed by antibiotic giant Cubist, who was a key factor in the acquisition of Mercit for $9.5 billion in late 2014 in the U.S market, Zerbaxa was approved at the end of 2014 and current indications are: (1) for the treatment of complex urinary tract infections (cUTI, including renine nephritis) caused by susceptible gram-negative bacteria in adult patients ;