2014年6月20日美国食品药品监督管理局(FDA)批准Sivextro(tedizolid phosphate)，一种新抗细菌药，治疗成年有皮肤感染。
Sivextro被批准治疗由某些易感细菌所致有急性细菌性皮肤和皮肤结构感染(ABSSSI)患者，包括金黄色葡萄球菌[Staphylococcus aureus](包括耐甲氧西林菌株[methicillin-resistant strains] (MRSA)和甲氧西林敏感菌株[methicillin-susceptible strains])，各种链球菌属[Streptococcus species]，和粪肠球菌[Enterococcus faecalis]。可得到为静脉和口服使用的Sivextro。
Sivextro是过去一个月中被FDA批准的第二个治疗ABSSSI的新抗细菌药。在2011年5月23日，监管局批准Dalvance (达巴万星[dalbavancin])，也治疗被金黄色葡萄球菌和各种链球菌属所致有ABSSSI患者。
FDA药品评价和研究中心的抗微生物产品室主任Edward Cox，M.D.，M.P.H说：“今天的批准提供医生和患者对严重有皮肤感染一种新治疗选择，”
对Sivextro应用，意向治疗严重或危及生命感染，被指定为一种合格的传染病产品(QIDP)和接受一种加快审评。Sivextro的QIDP指定还使它合格对另外五年专卖权将被添加至早已由食品，药品和化妆品法提供的某种专卖期。
在两项临床试验有1,315例成年有ABSSSI.参加者被随机赋予接受Sivextro或利奈唑胺[linezolid]，另一种抗细菌药被批准治疗ABSSSI评价Sivextro的安全性和疗效。结果显示为治疗ABSSSI Sivextro是与利奈唑胺一样有效。
在临床试验中被鉴定最常见副作用是恶心，头痛，腹泻，呕吐和眩晕。尚未在有白细胞水平减低(粒细胞减少) 患者中评价Sivextro的安全性和疗效，所以应考虑另外治疗。
Sivextro是由总部位于马萨诸塞州莱克星顿的Cubist药业上市。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402174.htm

详细的说明书:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=75672079-589f-451a-bdbf-eaebcfcc80a9
Tedizolid Phosphate SIVEXTRO™ (tedizolid phosphate) is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the potential treatment of complicated skin and soft tissue infections (cSSTI). In February 2014, the Company announced that the European Medicines Agency (EMA) accepted the tedizolid Marketing Authorization Application for review, with a decision expected from the European Commission (EC) during the first half of 2015. Tedizolid is also being developed for potential use in HABP/VABP, with Phase 3 pivotal studies progressing. About Serious Skin, Skin Structure and Soft Tissue Infections Acute bacterial skin and skin structure infections (ABSSSI) are also referred to as complicated skin and soft tissue infections (cSSTI) (in Europe). These infections, which are a significant and growing problem throughout the world, involve deeper tissue or require surgical intervention (e.g., cellulitis, major cutaneous abscesses and infected wounds) or are associated with a significant underlying disease (e.g., diabetes or systemic immunosuppression) that complicates response to therapy. A variety of pathogens may be identified in ABSSSI/cSSTI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of methicillin-resistant Staphylococcus aureus (MRSA) healthcare-associated infections (HAIs), as well as community infections, has resulted in a need for therapies to address serious skin, skin structure and soft tissue infections that are effective against MRSA. - See more at: http://www.cubist.com/products/tedizolid#sthash.yWjUkXgI.dpuf
Drug Name(s) SIVEXTRO
FDA Application No. (NDA) 205436
Active Ingredient(s) TEDIZOLID PHOSPHATE
Company CUBIST PHARMS
Original Approval or Tentative Approval Date June 20, 2014
Chemical Type 1  New molecular entity (NME)
Review Classification P  Priority review drug  
Action
Date
Supplement
Number
Approval
Type Letters,
Reviews,
Labels,
Patient Package Insert   Note
06/20/2014  000  Approval   Label (PDF)12
Letter (PDF)13