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Orexo的失眠用药Edluar获得了FDA的批准
作者:网络来源 时间:2009-04-01 点击:1198 来源:网络来源
<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0" align=left><FONT size=3><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Orexo</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">公司于</SPAN><?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /><st1:chsdate Year="2009" Month="3" Day="18" IsLunarDate="False" IsROCDate="False" w:st="on"><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">2009</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">年</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">3</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">月</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">18</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">日</SPAN></st1:chsdate><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">对外宣称美国</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">FDA</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">已批准其唑吡坦</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">(zolpidem</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">,</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Edluar/Sublinox)</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">舌下片,用于入睡困难失眠患者的短期治疗。本品有</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">5mg</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">和</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">10mg2</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">种规格。</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">2008</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">年,</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Orexo</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">公司的合作伙伴</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Meda</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">公司已获得了把本品推向全球市场的许可证,他们期望在</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">2009</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">年下半年把产品推向美国市场。</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Orexo</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">将从</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Meda</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">公司那里收取销售</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Edluar</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">的特许权费用。</SPAN><SPAN style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman"> <SPAN lang=EN-US><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></FONT></SPAN></FONT></P><BR> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan" align=left><FONT size=3><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Orexo</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">的首席执行官</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Torbjörn Bjerke </FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">在对外发表申明时称:</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">“FDA</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">批准</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Edluar</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">作为失眠症短期药物治疗使我非常开心,这是</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Orexo</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">的一个伟大收获。本品为一种舍下含片,其为失眠患者提供了更方便的治疗方案。预期的产品将会在</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">2009</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">年下半年入市,这将给</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Orexo</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">带来巨大利益。</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">” <o:p></o:p></FONT></SPAN></FONT></P><BR> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0" align=left><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">本品是唑吡坦的</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">1</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">种快速起效的舌下含片,</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">Orexo</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">公司通过的相关技术使得本品在舌下能经过口腔粘膜快速被吸收。唑吡坦是</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">1</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">种失眠症的临时治疗药物。</SPAN></FONT></P>
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