—ZERBAXA(ceftolozane/tazobactam)是本年度被批准的第四个的新抗菌药
2014年12月19日美国食品和药品监管局(FDA)批准Zerbaxa (ceftolozane/他唑巴坦[tazobactam])，一种新抗菌药产品，治疗成年有合并腹腔内感染(cIAI)和合并的泌尿道感染(cUTI)。
Zerbaxa是一种复方产品含ceftolozane，一种头孢菌素抗菌药，和他唑巴坦，一种β-内酰胺酶抑制剂。Zerbaxa被用于治疗cUTI，包括肾感染(肾盂肾炎)。与甲硝唑[metronidazole]联用治疗cIAI。
Zerbaxa是本年度被FDA批准的第四个新抗菌药。在5月监管局批准Dalvance (达巴万星[dalbavancin])，7月Sivextro (tedizolid)和8月Orbactiv (奥利万星[oritavancin])。
FDA药品评价和研究中心抗微生物产品室主任Edward Cox，M.D.，M.P.H说：“本年度几个新抗菌药的FDA批准证实监管局对患者和医生承诺增加治疗选择可供利用性，”“我们必须继续帮助促进新抗菌药的发展和鼓励谨慎使用现有方法以保留它们的效用。”
Zerbaxa是第四个被FDA批准接受指定为合格的传染病产品(QIDP)新抗菌药产品。题为FDA安全和创新法下现生成抗菌素激励(Generating Antibiotic Incentives Now ，GAIN)，Zerbaxa被授权QIDP指定，因为它是一种人用抗细菌或抗真菌药意向治疗某种严重或危及生命感染。
作为其QIDP指定的一部分，Zerbaxa被给予优先审评，它提供药物申请的一个加快审评。QIDP指定还使Zerbaxa合格享有另外五年独有营销添加至被食品，药品和化妆品法早已提供的某些独有营销期。
在一项总共979 例成年临床试验Zerbaxa与甲硝唑[metronidazole]联用治疗cIAI的疗效。参加者被随机赋予接受 Zerbaxa加甲硝唑或美罗培南[meropenem]，一种FDA-批准的抗菌药。结果确定Zerbaxa加甲硝唑有效治疗cIAI。
在一项临床试验其中1,068 例成年被随机赋予接受Zerbaxa或左氧氟沙星[levofloxacin]，一种抗菌药被FDA批准治疗CuTI，证实Zerbaxa 在治疗cUTI中有效。
Zerbaxa的说明书包括一个关于在肾受损患者中见到减低疗效的警告。在临床试验中被鉴定最常见副作用是恶心，腹泻，头痛和发热。制药上市。Dalvance由总部在芝加哥是的Durata Therapeutics上市，而Orbactiv是有总部在新泽西州帕西帕尼Medicines公司上市。

批准日期： 2014年12月19日；公司：Cubist
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427534.htm
Indication and Important Safety Information
Indications
ZERBAXA™ (ceftolozane/tazobactam) used in combination with metronidazole is indicated in adult patients for the treatment of complicated intra-abdominal infections (cIAI) caused by the following Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.
ZERBAXA™ is indicated in adult patients for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
Important Safety Information
•Hypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, or other members of the beta-lactam class. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials.   Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams.  If an anaphylactic reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy.
•Patients with renal impairment:  Decreased efficacy has been observed in patients with baseline CrCl of 30 to ≤50 mL/min. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly.
•Clostridium difficile–associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including ZERBAXA.  Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.  If CDAD is confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.
•Development of drug-resistant bacteria: Prescribing ZERBAXA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.
Adverse Reactions
The most common adverse reactions for ZERBAXA are nausea, diarrhea, headache and pyrexia.