FDA批准新款犬用注射抗生素:Zoetis的Convenia RTU单针提供最长14天疗效

美国食品药品监督管理局(FDA)2026年10月20日批准 Convenia RTU for Dogs(cefovecin injectable suspension,头孢维星注射悬液)上市,用于治疗犬的易感细菌性皮肤感染,包括继发性浅表脓皮病、脓肿与伤口,致病菌为易感的 Staphylococcus pseudintermedius 与 Streptococcus canis(G组)。FDA 将这一批准授予总部位于 Michigan 州 Kalamazoo 的 Zoetis Inc.。
新配方与原产品使用同一活性成分 cefovecin,区别有两点。一是浓度更高:新配方为 160 mg/mL,原 Convenia 为 80 mg/mL,同样剂量可用更小注射量完成;产品为 10 mL 多剂量瓶装、含 1,600 mg cefovecin 的即用型悬液,凭持牌兽医处方使用,每次使用前须摇匀60秒、用20号针头注射。二是新配方仅获批用于犬:其含有的 benzyl benzoate 与 propylene glycol 两种非活性成分可能对猫有毒性,不得用于猫。原 Convenia 于2008年获 FDA 批准,用于犬和猫的皮肤感染。
Convenia RTU 由兽医专业人员在诊所内皮下注射,单次给药可提供最长14天的抗菌治疗。据 Zoetis 发布,该产品与原 Convenia 生物等效,在一项研究中86%的犬只需一次 cefovecin 注射即解决细菌性皮肤感染。Zoetis 美国商业运营执行副总裁兼总裁 Abhay Nayak 表示,给犬连续一两周按时喂口服药对许多家庭并不容易,新配方延续了 Convenia 系列十余年的使用基础,让各种体型的犬都能用单次注射完成治疗。Zoetis 称该产品预计2027年第一季度起供应兽医。
安全信息方面,对青霉素或头孢类药物过敏的动物不得使用该产品,对这类药物过敏的人士应避免接触;已报告的副作用包括呕吐、腹泻、食欲下降与嗜睡。细菌性皮肤感染(脓皮病)是犬就诊的常见原因之一,这类细菌通常可存在于健康犬皮肤上,当抓挠、过敏或外伤破坏皮肤屏障时可迅速繁殖并引发感染。
FDA Approves Ready-to-Use Cefovecin Injectable: Zoetis Convenia RTU Gives Dogs Up to 14 Days of Treatment in One Shot
The U.S. Food and Drug Administration (FDA) on October 20, 2026, approved Convenia RTU for Dogs (cefovecin injectable suspension) for the treatment of susceptible bacterial skin infections in dogs, including secondary superficial pyoderma, abscesses and wounds caused by susceptible strains of Staphylococcus pseudintermedius and Streptococcus canis (Group G). The FDA granted the approval to Zoetis Inc., based in Kalamazoo, Michigan.
The new formulation contains the same active ingredient, cefovecin, as the original product, with two differences. It is more concentrated, at 160 mg/mL compared with 80 mg/mL for the original Convenia, so the same dose can be delivered in a smaller volume; it is supplied as a 10-mL multiuse vial containing 1,600 mg of cefovecin as a ready-to-use suspension, available by prescription from a licensed veterinarian, to be shaken for 60 seconds before each use and administered with a 20-gauge needle. It is also approved for dogs only: the formulation contains benzyl benzoate and propylene glycol, inactive ingredients that may be toxic to cats, and it must not be used in cats. The original Convenia was approved by the FDA in 2008 to treat skin infections in both dogs and cats.
Convenia RTU is administered by subcutaneous injection by a veterinary health professional and provides up to 14 days of antibiotic treatment in a single dose. Zoetis said the product is bioequivalent to Convenia, and that in one study 86% of dogs needed just one injection of cefovecin to resolve their bacterial skin infection. Abhay Nayak, Executive Vice President and President, U.S. Commercial Operations at Zoetis, said that giving a dog pills for a week or two on schedule is challenging for many families, and that the new formulation builds on the established Convenia portfolio for dogs of all sizes. Zoetis said the product is expected to be available to veterinarians in the first quarter of 2027.
On safety, the product must not be used in animals with a history of allergic reactions to penicillins or cephalosporins, and people with known hypersensitivity to penicillin or cephalosporins should avoid exposure; reported side effects include vomiting, diarrhea, decreased appetite and lethargy. The bacteria targeted by the drug can normally live on a healthy dog's skin without causing harm, but when scratching, allergies or injury compromise the skin barrier they can multiply rapidly and cause infection, and bacterial skin infection, or pyoderma, is among the most common reasons dogs are taken to a veterinarian.
来源:GSM·美国(原文链接)
图片来源:图:兽医诊室里坐在检查台上的小狗(资料图)。MarkBuckawicki 摄,CC0,经 Wikimedia Commons。Photo: a small dog on an examination table in a veterinary office (file photo), by MarkBuckawicki, CC0, via Wikimedia Commons.
GSM Global · 本篇英文版 English edition of this story

