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	<title>Symptom Advice .com &#187; 60 men</title>
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		<title>Avodart Gets Rejected By FDA For Reducing Prostate Cancer Risk : Shots &#8211; Health Blog : NPR</title>
		<link>http://symptomadvice.com/avodart-gets-rejected-by-fda-for-reducing-prostate-cancer-risk-shots-health-blog-npr/</link>
		<comments>http://symptomadvice.com/avodart-gets-rejected-by-fda-for-reducing-prostate-cancer-risk-shots-health-blog-npr/#comments</comments>
		<pubDate>Mon, 14 Feb 2011 04:17:08 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[prostate symptoms]]></category>
		<category><![CDATA[60 men]]></category>
		<category><![CDATA[cancers]]></category>
		<category><![CDATA[e mail]]></category>
		<category><![CDATA[food and drug]]></category>
		<category><![CDATA[food and drug administration]]></category>

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		<description><![CDATA[Even &#097;&#115; snow socked Washington, the Food and Drug Administration managed &#116;&#111; get a letter &#116;&#111; GlaxoSmithKline rejecting the company&#8217;s proposal &#116;&#111; sell the pill Avodart &#097;&#115; a way &#116;&#111; reduce the risk &#111;&#102; prostate cancer. The medicine, &#107;&#110;&#111;&#119;&#110; generically &#097;&#115; dutasteride, is prescribed &#116;&#111; ease the symptoms and reduce the need &#116;&#111; operate &#111;&#110; [...]]]></description>
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<p>Even &#097;&#115; snow socked Washington, the Food and Drug Administration managed &#116;&#111; get a letter &#116;&#111; GlaxoSmithKline rejecting the company&#8217;s proposal &#116;&#111; sell the pill Avodart &#097;&#115; a way &#116;&#111; reduce the risk &#111;&#102; prostate cancer.</p>
<p>The medicine, &#107;&#110;&#111;&#119;&#110; generically &#097;&#115; dutasteride, is prescribed &#116;&#111; ease the symptoms and reduce the need &#116;&#111; operate &#111;&#110; enlarged prostates. Glaxo &#104;&#097;&#115; &#098;&#101;&#101;&#110; looking &#116;&#111; get the drug approved &#102;&#111;&#114; the prevention &#111;&#102; prostate cancer &#105;&#110; men &#119;&#105;&#116;&#104; high PSAs and who&#8217;ve &#104;&#097;&#100; a biopsy &#102;&#111;&#114; prostate cancer &#116;&#104;&#097;&#116; didn&#8217;t &#102;&#105;&#110;&#100; any.</p>
<p> &nbsp;
<p>Back &#105;&#110; December, a panel &#111;&#102; experts advising the FDA about the proposal voted it down 14-2 &#098;&#101;&#099;&#097;&#117;&#115;&#101; the benefit &#111;&#102; reducing &#115;&#111;&#109;&#101; cancers didn&#8217;t outweigh the risks &#116;&#104;&#097;&#116; &#115;&#111;&#109;&#101; aggressive cancers &#119;&#111;&#117;&#108;&#100; go unnoticed.</p>
<p>FDA said &#097;&#116; the meeting &#116;&#104;&#097;&#116; the company&#8217;s data showed 60 men &#119;&#111;&#117;&#108;&#100; need &#116;&#111; &#098;&#101; treated &#119;&#105;&#116;&#104; Avodart &#102;&#111;&#114; four years &#116;&#111; prevent a single &#8220;clinically meaningful&#8221; case &#111;&#102; prostate cancer, the Wall Street Journal reported &#097;&#116; the time. Among the &#115;&#097;&#109;&#101; men over the &#115;&#097;&#109;&#101; period, about 1 &#105;&#110; 200 treated &#119;&#105;&#116;&#104; Avodart &#119;&#111;&#117;&#108;&#100; develop an aggressive type &#111;&#102; prostate cancer.</p>
<p>In an e-mail, a Glaxo spokesman said the company is still reviewing the letter, which it received &#097;&#114;&#111;&#117;&#110;&#100; 7 p.m. Wednesday. (That&#8217;s &#119;&#104;&#101;&#110; parts &#111;&#102; suburban Washington &#110;&#101;&#097;&#114; FDA headquarters were hit &#119;&#105;&#116;&#104; thundersnow.) Glaxo expects &#116;&#111; talk it over &#119;&#105;&#116;&#104; the agency, &#098;&#117;&#116; the company hasn&#8217;t &#109;&#097;&#100;&#101; a &#100;&#101;&#099;&#105;&#115;&#105;&#111;&#110; about whether &#116;&#111; continue work &#111;&#110; approval.</p></p>
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