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FDA批准强的松强的松延迟释放片
作者:网络来源 时间:2012-07-31 点击:348 来源:网络来源
<P style="BACKGROUND: whitesmoke; MARGIN: 0cm 0cm 0pt; VERTICAL-ALIGN: top; 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 style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">Horizon</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">制药公司</SPAN> <SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">7</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; 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: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">26</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; 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: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">宣布,美国</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">批准其强的松(</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">prednisone</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; 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 lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Rayos</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">缓释片(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">1</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; 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: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">2</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">毫克和</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">5</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; 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),用以广泛治疗一系列疾病,包括类风湿关节炎(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">RA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">)、风湿性多肌痛(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">PMR</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">),银屑病关节炎(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">PSA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">),强直性脊柱炎(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">AS</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">),哮喘和慢性阻塞性肺疾病(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">COPD</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; 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 lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">这项批准有将</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Rayos</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">药代动力学与速释强的松和强的松类风湿关节炎类风湿关节炎昼夜给药(</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">CAPRA-1</SPAN> <SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ansi-language: en; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">和</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">2</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">)试验数据相联系的数据支持。</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">CAPRA- 2</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ansi-language: en; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">使用显示</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">,中</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">CAPRA-1</SPAN> <SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">试验支持的</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Rayos</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">整体安全性。</SPAN></P>
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