Prasugrel Delayed | Clipmarks


	Prasugrel Delayed

Matthew Herper

6-23-2008 6:38 PM

794 views

Matthew Herper says:

The Food and Drug Administration will take another three months to make a decision on Lilly's blood thinner. Given the lack of an advisory panel and the controversy surrounding the drug, this is not a huge surprise. Exactly what info the FDA needs going forward is not clear.

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<div style="margin: 12px 0px; font-family: arial; color: #333333; background: #ffffff; border: solid 4px #e5e5e5; width: 100%; clear: left;"><div class="CM_CTB_Content_Wrap" style="margin: 0px; padding: 0px;background-color: #ffffff;"><div style="border-bottom: solid 1px #dcdcdc; white-space: nowrap; margin-bottom: 8px; background-color: #eeeeee ;background-image: url(http://clipmarks.com/images/source-bg.gif); background-repeat: repeat-x; height: 24px; line-height: 24px; vertical-align: middle; padding-bottom: 4px; color: #666666; font-size: 10px;" ><a href="http://clipmarks.com/clip-to-blog/" title="see clips that are hot right now"><img src="http://content.clipmarks.com/blog_embed/858cd023-fd2e-47ca-a961-af765e9748ad/CD823385-35D5-400A-9FCE-8872B4F802D2/" alt="" width="19" height="19" border="0" style="vertical-align: middle; margin: 0px 4px; display: inline; border: none; float:none;" /></a>clipped from <a title="http://biz.yahoo.com/prnews/080623/clm124.html?.v=53" href="http://biz.yahoo.com/prnews/080623/clm124.html?.v=53" style="font-size: 11px;">biz.yahoo.com</a></div><blockquote style="text-align: left; padding: 0px 8px; margin: 4px 0px 8px 0px; background: transparent; border: none;" cite="http://biz.yahoo.com/prnews/080623/clm124.html?.v=53"><SPAN class="t">FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel</SPAN></blockquote><div style="height: 2px; font-size: 2px; background: #dcdcdc; border-bottom: solid 1px #f5f5f5; margin: 2px 4px;"></div><blockquote style="text-align: left; padding: 0px 8px; margin: 4px 0px 8px 0px; background: transparent; border: none;" cite="http://biz.yahoo.com/prnews/080623/clm124.html?.v=53"><P><SPAN class="t2"></SPAN>
</P><P></P><DIV class="ar">TOKYO and INDIANAPOLIS, June 23 /PRNewswire-FirstCall/ -- Daiichi Sankyo
Company, Limited, (TSE:<A href="http://finance.yahoo.com/q?s=4568.to&d=t">4568</A> - <A href="http://finance.yahoo.com/q/h?s=4568.to">News</A>) and Eli Lilly and Company (NYSE: <A href="http://finance.yahoo.com/q?s=lly&d=t">LLY</A> - <A href="http://finance.yahoo.com/q/h?s=lly">News</A>) said that
the U.S. Food and Drug Administration (FDA) has extended the review period for
the prasugrel new drug application (NDA) based on supplemental information
provided during the review period.  This three month extension allows the FDA
time to complete its review.  The prasugrel NDA was granted priority review by
the FDA in February 2008.  The new FDA action date for prasugrel is September
26, 2008.  The proposed indication for prasugrel is for the treatment of
patients with acute coronary syndromes (ACS) being managed with an artery-
opening procedure known as percutaneous coronary intervention (PCI).</DIV></blockquote></div><div style="margin: 0px 6px 6px 4px;"><table style="font-size: 11px;border-spacing: 0px;padding: 0px;" cellpadding="0" cellspacing="0" width="100%"><tr><td style="background:transparent;border-width:0px;padding:0px;">&nbsp;</td><td align="right" style="background:transparent;border-width:0px;padding:0px;width:107px" width="107"><a href="http://clipmarks.com/share/CD823385-35D5-400A-9FCE-8872B4F802D2/blog/" title="blog or email this clip"><img src="http://content8.clipmarks.com/images/c2b-foot.png" border="0" alt="blog it" width="107" height="17" style="border-width:0px;padding:0px;margin:0px;" /></a></td></tr></table></div></div>

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