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英语翻译Paris,April 15,2013 -BioAlliance Pharma SA (Euronext Par

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英语翻译
Paris,April 15,2013 -BioAlliance Pharma SA (Euronext Paris - BIO),announced the receipt of marketing authorization from the U.S.Food and Drug Administration (FDA) forSitavigin the treatment of recurring Herpes labialis,marking the successful conclusion to the assessment procedure carried out by the American authorities.
After Loramyc®,registered in 26 countries including the United States,BioAlliance Pharma for the second time has successfully passed the FDA review.The registration of Sitavig,developed internally,shows once again the teams’ capacity and expertise.
Based on proprietary Lauriad® technology,Sitavig comes in the form of a mucoadhesive tablet which the patient places on the gum and which delivers a high concentration of acyclovir directly to the lip,the site of the cold sore infection.In a phase III international study conducted on 775 patients,Sitavig demonstrated a high level of efficacy in terms of healing time with one single tablet containing 50 mg of acyclovir and an excellent tolerance profile.In addition to its efficacy,Sitavig offers a unique unobtrusive and simple formulation with a single application for the episode's entire duration,representing major advantages for patients suffering from recurrent herpes sores.
“Herpes labialis is an infection that affects a very large number of patients around the world and for which there is a real need for effective treatment with appropriate presentation.We participated in the phase III clinical trial in our center and were able to test the benefits of Sitavig.We are very pleased with the outcome of this development which will allow patients,once the product is on the market,to have a drug that meets their needs," says Professor Stephen Keith Tyring of the Dermatology Department at the University of Texas Health Sciences Center in Houston.
巴黎,2013年4月15日-生物联盟制药公司(巴黎泛欧生物交易所),宣布从美国食品和药物管理局(FDA)营销授权收到(for Sitavigin不知道)复发性唇疱疹的治疗,标志着美国当局进行了评估程序,结论的成功.
(Loramyc®不会后,包括美国在内的26个国家注册,生物联盟制药的第二次成功地通过了美国FDA的审查.登记(sitavig不会),内部开发的,再次显示了团队的能力和专业知识.
基于专有的(lauriad®不会)技术,(sitavig)出现在一个粘附片的病人放在胶的形式和它提供的阿昔洛韦浓度高到唇,冷疮感染的网站.在第三阶段的国际研究的775例患者进行了论证,sitavig在愈合时间方面疗效高水平与一个单一的片含有50毫克阿昔洛韦和良好的耐受特征.除了其疗效,(sitavig)提供了一个独特不显眼的,简单的事件,整个持续时间的单个应用程序的制定,代表患有复发性疱疹患者的主要优点
“唇疱疹是一种影响世界各地的患者数量非常大,有适当的提示有效的治疗需要一个真正的感染.我们参加了在我们中心的第三期临床试验,能够测试(sitavig不会)的好处.我们对这方面的发展,将使患者的预后非常高兴,一旦该产品在市场上,有一种药能满足他们的需求,”史蒂芬教授说基思试着在休斯敦的德克萨斯大学医学中心皮肤科.
有好多词太过专业,我也不知道