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	<title>Drug Kennel</title>
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	<description>Drug Development Comments - Focused on 505(b)(2)</description>
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		<title>ViroPharma loses exclusivity appeal</title>
		<link>http://www.camargoblog.com/index.php/2012/04/30/viropharma-loses-exclusivity-appeal/</link>
		<comments>http://www.camargoblog.com/index.php/2012/04/30/viropharma-loses-exclusivity-appeal/#comments</comments>
		<pubDate>Mon, 30 Apr 2012 13:05:11 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[505(b)(2) Issues]]></category>
		<category><![CDATA[ANDA's]]></category>
		<category><![CDATA[News Commentary]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1397</guid>
		<description><![CDATA[As I wrote last week, on 4/9/12 the FDA denied ViroPharma&#8217;s request for 3-year exclusivity for its antibiotic Vancocin and approved three generics.  ViroPharma immediately sued the heads of FDA and HHS and their Agencies.  In a U.S. District Court decision, the judge denied ViroPharma&#8217;s motions to grant a  preliminary injunction to require that FDA withdraw the ANDA [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Supreme Court upholds counterclaim provision for overbroad Orange Book Use Codes entries in ANDA patent infringement suits</title>
		<link>http://www.camargoblog.com/index.php/2012/04/20/supreme-court-upholds-counterclaim-provision-for-overbroad-orange-book-use-codes-entries-in-anda-patent-infringement-suits/</link>
		<comments>http://www.camargoblog.com/index.php/2012/04/20/supreme-court-upholds-counterclaim-provision-for-overbroad-orange-book-use-codes-entries-in-anda-patent-infringement-suits/#comments</comments>
		<pubDate>Fri, 20 Apr 2012 20:31:43 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[505(b)(2) Issues]]></category>
		<category><![CDATA[ANDA's]]></category>
		<category><![CDATA[News Commentary]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1385</guid>
		<description><![CDATA[It’s happened in most generic product development programs:  A likely looking drug product candidate is selected and the due diligence begins.  A review of the Orange Book shows one or more “use code” patents listed for the RLD.  A review of the actual patent reveals that the use code description (supplied by the RLD holder [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>ViroPharma denied request for 3-year exclusivity</title>
		<link>http://www.camargoblog.com/index.php/2012/04/19/viropharma-denied-request-for-3-year-exclusivity/</link>
		<comments>http://www.camargoblog.com/index.php/2012/04/19/viropharma-denied-request-for-3-year-exclusivity/#comments</comments>
		<pubDate>Thu, 19 Apr 2012 23:51:10 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[505(b)(2) Issues]]></category>
		<category><![CDATA[News Commentary]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1367</guid>
		<description><![CDATA[ViroPharma has pulled out all stops to prevent generic copies of its off-patent Vancocin® capsule (vancomycin hydrochloride) including the use of the Citizen Petition process.  Recently, FDA denied most of the requests  in their Citizen Petition and simultaneously approved generics from 3 companies.  ViroPharma immediately responded by filing a suit against the FDA. A reading of the [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Drug Development Planned Like the Titanic</title>
		<link>http://www.camargoblog.com/index.php/2012/04/15/drug-development-planned-like-the-titanic/</link>
		<comments>http://www.camargoblog.com/index.php/2012/04/15/drug-development-planned-like-the-titanic/#comments</comments>
		<pubDate>Sun, 15 Apr 2012 14:00:04 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[505(b)(2) Process]]></category>
		<category><![CDATA[CMC Issues]]></category>
		<category><![CDATA[Formulation Issues]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1343</guid>
		<description><![CDATA[How many drug development companies leave it up to the CRO or CMO to design or execute their studies or formulation/manufacturing without oversight?   Like those who boarded the Titantic 100 years ago, they seem to trust the mantra that their contractor&#8217;s work is unsinkable.  MAP Pharmaceuticals seemed to do just that &#8211; the approval of their [...]]]></description>
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		<slash:comments>0</slash:comments>
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		<item>
		<title>NIH Head Urges Repositioning/Repurposing</title>
		<link>http://www.camargoblog.com/index.php/2012/04/12/nih-head-urges-repositioningrepurposing/</link>
		<comments>http://www.camargoblog.com/index.php/2012/04/12/nih-head-urges-repositioningrepurposing/#comments</comments>
		<pubDate>Thu, 12 Apr 2012 20:32:43 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[News Commentary]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1359</guid>
		<description><![CDATA[In a speech at yesterday’s 2012 TEDMED conference, the head of the NIH, Dr. Francis Collins, said  that there is a big gap between basic research and drugs for patients.  To bridge this gap he suggested &#8216;some of those old drugs could be re-purposed — or taught new tricks&#8217; &#8211; hey, that&#8217;s our tag line! [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Generic vs. 505(b)(2) Failure-to-Warn Liability</title>
		<link>http://www.camargoblog.com/index.php/2012/04/02/generic-vs-505b2-failure-to-warn-liability/</link>
		<comments>http://www.camargoblog.com/index.php/2012/04/02/generic-vs-505b2-failure-to-warn-liability/#comments</comments>
		<pubDate>Mon, 02 Apr 2012 13:41:04 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[505(b)(2) Issues]]></category>
		<category><![CDATA[ANDA's]]></category>
		<category><![CDATA[Events]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1341</guid>
		<description><![CDATA[A recent editorial (may need subscription) in the New York Times opined that a recent Supreme Court decision &#8211; a &#8220;bizarre outcome&#8221; - &#8220;makes it virtually impossible to sue generic manufacturers for failing to provide adequate warning of a prescription drug’s dangers.&#8221;   The court case the Times is referring to is Pliva Inc. v. Mensing .   In [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals</title>
		<link>http://www.camargoblog.com/index.php/2012/01/09/2011-505b2-approvals-now-exceed-505b1-nda-approvals/</link>
		<comments>http://www.camargoblog.com/index.php/2012/01/09/2011-505b2-approvals-now-exceed-505b1-nda-approvals/#comments</comments>
		<pubDate>Mon, 09 Jan 2012 16:14:11 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[505(b)(2) Process]]></category>
		<category><![CDATA[Events]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1335</guid>
		<description><![CDATA[What a year for 505(b)(2) drug development!  In 2011 FDA approved 44 505(b)(2) NDA submissions.  Various authors have reported that FDA approved 34 or 35 drugs in 2011 (505(b)(1) NDA + BLA).  I had speculated a couple of years ago that perhaps 80% of new drugs approved  in 2012 would be 505(b)(2)&#8217;s, based on botha  [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>What is an Approved DESI Product?</title>
		<link>http://www.camargoblog.com/index.php/2011/12/21/what-is-an-approved-desi-product/</link>
		<comments>http://www.camargoblog.com/index.php/2011/12/21/what-is-an-approved-desi-product/#comments</comments>
		<pubDate>Wed, 21 Dec 2011 15:25:39 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[505(b)(2) Issues]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1317</guid>
		<description><![CDATA[I am hesitant to contribute more information about so-called DESI drugs at the risk of further confusion.  My goal is always to provide clarity, so here goes. Fundamental to any discussion about DESI products is the definition of a drug product.  Let&#8217;s just focus on one part of the definition &#8211; the labeling.  A drug [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Stability Changes coming to ANDAs</title>
		<link>http://www.camargoblog.com/index.php/2011/10/04/stability-changes-coming-to-andas/</link>
		<comments>http://www.camargoblog.com/index.php/2011/10/04/stability-changes-coming-to-andas/#comments</comments>
		<pubDate>Tue, 04 Oct 2011 19:03:13 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[ANDA's]]></category>
		<category><![CDATA[News Commentary]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1310</guid>
		<description><![CDATA[This post comes from D.C. where I am attending the GPhA Fall Technical Conference.  We just completed a presentation by FDA&#8217;s Glen Smith.  He  detailed the proposed new stability requirements for ANDA drug products.  It is essentially the adoption of ICH Q1A.  For readers of this blog, we know that 505(b(2) NDA&#8217;s must have 12 months [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Don&#8217;t launch unapproved products after 9/19/2011</title>
		<link>http://www.camargoblog.com/index.php/2011/10/03/dont-launch-unapproved-products-after-9192011/</link>
		<comments>http://www.camargoblog.com/index.php/2011/10/03/dont-launch-unapproved-products-after-9192011/#comments</comments>
		<pubDate>Mon, 03 Oct 2011 20:48:33 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[505(b)(2) Issues]]></category>

		<guid isPermaLink="false">http://www.camargoblog.com/?p=1307</guid>
		<description><![CDATA[I had a call from a client who wondered if he could launch a new &#8216;DESI&#8217; product. He had just read the FDA&#8217;s recent announcement that it would take immediate enforcement action on any unapproved drug introduced into the market after September 19, 2011. So, the question he asked was, is his &#8220;DESI&#8221; drug an [...]]]></description>
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