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【drug-news】欧加农公司抗抑郁药mirtazapine将于20
2007年一月11日荷兰化学集团Akzo Nobel公司下属的医疗保健机构Organon（欧加农）公司宣称今天已经向日本卫生局递交新抗抑郁药米尔塔扎平（在大多数国家叫做瑞美隆）新药2007年中期上市的申请，晚于预期三年。
This is very exciting news for us, “said Emile van Dongen, executive vice president global sales. “The Japanese market is an important market and we are confident that mirtazapine’s fast onset of action and tolerability will make it a first line option for the treatment of depression in Japan.”
“这对我们来说是一个激动人心的消息，”负责全球销售业务的执行副总裁Emile van Dongen说，“日本是一个重要的市场，米尔塔扎平的快速起效和耐受性好的特点将使它成为日本治疗抑郁症的一线药物我们对此很有信心。”
Mirtazapine - a Noradrenergic and Selective Serotonergic Antidepressant (NaSSA) - has been available in other countries since 1994. Mirtazapine has a unique mechanism of action and has been proven safe and effective in the treatment of major depression in many countries. Nippon Organon has been developing mirtazapine in Japan for depression in partnership with Meiji Seika Kaisha since 2004.
米尔塔扎平作为一种去肾上腺素能和选择性5-羟色胺类抗抑郁药，从1994年起已在其它国家上市。米尔塔扎平发挥作用的机制独特，在很多国家的临床治疗中证明可以安全有效的用于治疗抑郁症，从2004年起，日本的Organon公司一直在和Meiji Seika Kaisha合作进行米尔塔扎平治疗抑郁症的研究。
The Phase IIb trials in the Japanese population demonstrated superior efficacy of mirtazapine over placebo. Earlier this year Nippon Organon and Meiji Seika Kaisha discussed how to further develop mirtazapine with the Japanese health authorities. As a result of this discussion they are now confident that they can submit an NDA in Japan some time towards the middle of 2007.
在日本病人体内进行的二期b阶段的临床实验表明，米尔塔扎平的效力远远高于对照品。今年初，Organon和Meiji Seika Kaisha讨论如何深入地和日本卫生部门共同研究开发米尔塔扎平。作为讨论的成果，这两家公司有把握在2007年的中期的某个时候递交DNA基因图。
Hans van Eerd, Organon Nippon’s general manager added: “The efforts and hard work of all the teams involved, Nippon Organon team, global mirtazapine team and our developmental partner Meiji Seika Kaisha have driven this success.”
Hans van Eerd, Organon Nippon的总经理又补充到：“这包含了相关团队部门的努力和辛勤的工作，正是由于Nippon Organon团队、全球米尔塔扎平开发部门以及我们的开发合作方Meiji Seika Kaisha的共同努力才造就了现在的成功。
About Organon
Organon – with shared head offices in Roseland, NJ, USA and Oss, The Netherlands – creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology. Organon products are sold in over 100 countries, of which more than 50 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.
关于米塞林
Organon——在美国新泽西州Roseland与荷兰的Oss分别设立总部——开发、生产并使其作为新处方药上市，这将改善人们的健康和生活质量。Organon将会努力保持或成为每一个核心治疗领域生物制药公司的领头羊之一：生育、妇科、麻醉、神经科学。研究范围也包括免疫和肿瘤。Organon的产品销往100多个国家，其中50个以上的国家有Organon的子公司。Organon公司是荷兰化学集团Akzo Nobel公司下属的医疗保健机构。 submit an NDA in Japan some time towards the middle of 2007.
在2007年中期向日本递交新药申请.
NDA的英文应该是new drug application mirtazapine 米氮平
Noradrenergic 去甲肾上腺素
placebo 安慰剂 而不是 对照品
NDA 新药申请 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-06-16 05:11
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