合理用药
不良反应
新药前沿
药物治疗
关键字:
搜索栏目:
 首页 >> 合理用药 >> 新药前沿
FDA批准处方级鱼油丸
作者:网络来源 时间:2012-07-31 点击:333 来源:网络来源
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">美国</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">上周于</SPAN> <SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">7</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">26</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">日</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">批准</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Amarin</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">公司的处方鱼油丸用于治疗高甘油三酯血症(这类患者血液中甘油三酯水平很高)。</SPAN></P> <P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Amarin</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">公司获准的这种名为</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Vascepa</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">的鱼油丸中的原料系从超纯</SPAN><SPAN lang=ZH style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial; mso-fareast-language: ZH" XML:LANG="ZH">二十碳五烯酸乙酯</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-fareast-language: ZH" XML:LANG="EN-US">(EPA-E</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial" XML:LANG="EN-US">)</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">,即一种</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">通常在鱼类中发现的</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">ω-3</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">脂肪酸制得。</SPAN></P> <P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">的该批准决定没有是否给予</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Vascepa</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">像一个新的化学实体(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">NCE</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">)那种</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">5</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">年市场独占权。在</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Vascepa</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">批准消息公布之前,</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Amarin</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">公司股票涨停,股价为每股</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">15.31</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">美元。</SPAN></P> <P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">在一项</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">III</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">期临床试验中,招募的高基线甘油三酯水平(大于</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">500</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">毫克</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">/</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">分升)患者每日摄入最高剂量</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Vascepa</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">,甘油三酯的水平相比安慰剂降低</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">33</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">%。</SPAN> <SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt"><SPAN lang=EN-US XML:LANG="EN-US"><FONT face=Arial>Vascepa</FONT></SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">不会引起低密度脂蛋白(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">LDL</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">)或“坏”胆固醇明显升高。</SPAN></P> <P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Amarin</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">公司计划在</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">2013</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: black; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">年一季度推出。</SPAN></P>
返回>>>
浙江省医院药事管理质控中心网 版权所有@2008 All Right Reserved。 浙江省医院药事管理质控中心主办
地址:杭州市庆春路79号(310003)        Email:zhejiangyszk@163.com
建议浏览器IE6.0+ 分辨率:1024*768以上