Ranbaxy Launches Generic Valtrex In US As Patent Expires

<p> One more drug that is coming off patent and Ranbaxy in New Jersey will have a 180 day exclusive for marketing.  Valtrex now having a generic should be cheaper and more affordable real soon. Ranbaxy is a division of Daiichi Sankyo in Japan.  For a little history on the purchase of Ranbaxy, formerly an Indian owned company you can read up here.  Ranbaxy has been under the eye of the FDA more than once.  They hired Rudy Giuliani to help get them through the legal portions of the purchase.  <a href="http://lh5.ggpht.com/_v3zjJigoAPE/SxKnn25jcLI/AAAAAAAAbLM/TyCwJyiKY8I/s1600-h/image%5B4%5D.png"><img align="right" alt="image" border="0" height="171" src="http://lh5.ggpht.com/_v3zjJigoAPE/SxKnps2MrII/AAAAAAAAbLQ/9fAxg5ljGfQ/image_thumb%5B2%5D.png?imgmax=800" style="border-bottom: 0px; border-left: 0px; display: inline; margin-left: 0px; border-top: 0px; margin-right: 0px; border-right: 0px" title="image" width="196" /></a> </p> <h4><a href="http://ducknetweb.blogspot.com/2008/09/ranbaxy-finds-rudy-giuliani-is-for-hire.html"><font size="2">Ranbaxy Finds Rudy Giuliani is for hire..</font></a></h4> <p>Valtrex has been a big cash cow for Glaxo and now faces competition in the field of generics.  The original post below discusses 3 drugs given approval in 2007 for Ranbaxy to produce.  BD  </p> <h4><a href="http://ducknetweb.blogspot.com/2007/02/first-time-generic-approvals-focalin.html"><font size="2">First-Time Generic Approvals: Focalin, Valtrex, Hydrodiuril</font></a></h4> <blockquote> <p>BANGALORE (Dow Jones)--Ranbaxy Laboratories Ltd. (500359.BY) Friday said it has launched a generic version of GlaxoSmithKline's (GSK.LN) anti-herpes medicine Valtrex in the U.S., a development expected to significantly boost its financial results. </p> <p>Ranbaxy--a unit of Japan's Daiichi Sankyo Co.--launched the generic drug, valacyclovir hydrochloride, in the U.S on Nov. 25. </p> <p>The news underscores Ranbaxy's confidence that, despite facing regulatory issues in the U.S., it will not miss out on opportunities stemming from being the first to file generic applications with the Food and Drug Administration. </p> <p>Ranbaxy will have a 180-day exclusive marketing period for the medicine as "first-to-file" status lets it be the only maker of the drug, other than GlaxoSmithKline, for the first six months from the patent's expiry.</p> <p>Ranbaxy had previously lost out on a lucrative opportunity to be the first to launch a generic version of GlaxoSmithKline's migraine drug Imitrex in the U.S. because of a delay in receiving FDA approval.</p> </blockquote> <p><a href="http://online.wsj.com/article/BT-CO-20091127-702103.html">UPDATE: Ranbaxy Launches Generic Valtrex In US, Shares Rise - WSJ.com</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:c557823d-89de-4326-b5dc-5f0096bc47ec" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Ranbaxy" rel="tag">Ranbaxy</a>,<a href="http://technorati.com/tags/Valtrex" rel="tag">Valtrex</a>,<a href="http://technorati.com/tags/pharma" rel="tag">pharma</a>,<a href="http://technorati.com/tags/patents" rel="tag">patents</a>,<a href="http://technorati.com/tags/healthcare" rel="tag">healthcare</a>,<a href="http://technorati.com/tags/valacyclovir" rel="tag">valacyclovir</a>,<a href="http://technorati.com/tags/herpes" rel="tag">herpes</a>,<a href="http://technorati.com/tags/shingles" rel="tag">shingles</a>,<a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/GlaxoSmithKline" rel="tag">GlaxoSmithKline</a></div>

Ranbaxy Launches Generic Valtrex In US As Patent Expires

One more drug that is coming off patent and Ranbaxy in New Jersey will have a 180 day exclusive for marketing.  Valtrex now having a generi...

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FDA Halts Drug Exports From A Fourth Ranbaxy Laboratory In India

<p>The facility located in Toansa is the facility that received the restrictions from the FDA. <img align="right" alt="image" border="0" height="150" src="http://lh6.ggpht.com/-PybkKKcnO8s/UuIJBYCK5NI/AAAAAAABJNI/skxNvApQJjU/image%25255B4%25255D.png?imgmax=800" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; float: right; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" title="image" width="220" /> The company supplies a lot of generic drugs  to the US.  This is not the first issue with products from the company as in 2012 the facility in Paonta signed a consent decree to ensure compliance with the FDA.  This makes for a total of 4 plants in India being banned from the US.  Due to past issues the company was pretty much supplying the raw materials to US Ranbaxy and other drug plants as the former problems pretty much took them out of the loop for sending finished products to the US.  </p> <p>The company will need to use a 3rd party to assess the situation and remedy the manufacturing and content solutions.  In addition raw materials already at facilities in the US cannot be distributed.  The company is still bouncing back from the whistle blower case where Ranbaxy was fined $500 million.  The video on the fines settled last year explains the FDA investigation with a long past with Ranbaxy.  </p> <p><embed src="http://www.cbsnews.com/common/video/cbsnews_player.swf" scale="noscale" salign="lt" type="application/x-shockwave-flash" background="#000000" width="425" height="279" allowFullScreen="true" allowScriptAccess="always" FlashVars="pType=embed&si=254&pid=Ak4Swww6exDj&url=http://www.cbsnews.com/video/whistleblower-reveals-how-drug-company-faked-results" /></embed></p> <p>The data from Ranbaxy was a dark hole and the company had a pattern of submitting data with errors.  There is not yet a list of what drugs will be affected and the FDA states they are immediately looking for any areas to where the a drug shortage could take place.  BD  </p> <p> <hr />The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289224.htm">consent decree</a> of permanent injunction entered against Ranbaxy in January 2012.</p> <p>The decree contains, among other things, provisions to ensure compliance with current good manufacturing practice (CGMP) requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy’s <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368445.htm">Mohali</a> facility to the CGMP provisions of the decree.</p> <p>Under the decree, the FDA has issued an order prohibiting Ranbaxy from:</p> <p>• distributing in the United States drugs manufactured using API from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey; <br />• manufacturing API at its Toansa facility for FDA-regulated drug products; <br />• exporting API from Toansa to the United States for any purpose; and <br />• providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.</p> <p>“We are taking swift action to prevent substandard quality products from reaching U.S. consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that the drugs American consumers receive – no matter where they are produced – meet quality standards and are safe and effective.”</p> <p>The FDA’s <a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf">inspection</a> of the Toansa facility, which concluded on Jan. 11, 2014, identified significant CGMP violations. These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.</p> <p>The agency is evaluating potential drug shortage issues that may result from this action. If the FDA determines that a medically necessary drug is in shortage or at risk of shortage, the FDA may modify this order to preserve patient access to drugs manufactured under controls that are sufficient to assure quality, safety and effectiveness.</p> <p><a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm" title="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm">http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm</a></p>

FDA Halts Drug Exports From A Fourth Ranbaxy Laboratory In India

The facility located in Toansa is the facility that received the restrictions from the FDA. The company supplies a lot of generic drugs  to...

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Ranbaxy Recall of Generic Lipitor: Dose Mix Up 20 Milligram Bottles Found To Contain 10 Milligram Does

<p>The FDA upon their latest recent visit has pretty much stopped all exports of the drug or the active ingredient exports to the US and now a US pharmacist found this most recent problem with<img align="right" alt="image" border="0" height="143" src="http://lh4.ggpht.com/-89_OMyg18YE/UxzFIuqRmwI/AAAAAAABJjY/JRKdpbfiUoE/image%25255B3%25255D.png?imgmax=800" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; float: right; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" title="image" width="232" /> the mix up with 10 milligram products in the 20 milligram bottles.  Once the patent came off Lipitor both Teva and Ranbaxy raced to get the generic product on the market.  </p> <h5><a href="http://ducknetweb.blogspot.com/2014/01/fda-halts-drug-exports-from-fourth.html">FDA Halts Drug Exports From A Fourth Ranbaxy Laboratory In India</a></h5> <h5><a href="http://ducknetweb.blogspot.com/2012/11/ranbaxy-recalling-generic-version-of.html">Ranbaxy Recalling Generic Version of Lipitor–Small Particles of Glass Contamination Cites</a></h5> <h5><a href="http://ducknetweb.blogspot.com/2011/11/teva-and-ranbaxy-agreement-announced.html">Teva and Ranbaxy Agreement Announced for the Sale of Generic Lipitor</a></h5> <p>It’s a good thing we have “some” checks and balances here with a pharmacist verifying content here in the sealed bottle which of course tells us it came from the manufacturing end of the business.  BD</p> <p><a href="http://www.bloomberg.com/quote/RBXY:IN"> <hr />Ranbaxy Laboratories Ltd. (RBXY)</a>, <a href="http://topics.bloomberg.com/india/">India</a>’s largest drugmaker, has recalled two batches of the company’s generic version of <a href="http://www.bloomberg.com/quote/PFE:US">Pfizer Inc. (PFE)</a>’s cholesterol-lowering medicine Lipitor after a dose mix-up was detected. </p> <p>Ranbaxy, a unit of Tokyo-based <a href="http://www.bloomberg.com/quote/4568:JP">Daiichi Sankyo Co. (4568)</a>, is pulling back pills in 64,626 bottles of atorvastatin calcium in the U.S. after a “product complaint” was received by a pharmacist, the U.S. <a href="http://topics.bloomberg.com/food-and-drug-administration/">Food and Drug Administration</a> <a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1086-2014&w=03052014&lang=eng">said</a> on its website. The pharmacist had discovered a 20 milligram tablet in a sealed bottle marked for 10 milligram pills, the FDA said. </p> <p>The nationwide recall comes on the back of increasing <a href="http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda/ucm118411.htm">scrutiny</a> on Ranbaxy, all four of whose Indian facilities are suspended from selling in the U.S. for failing to meet the FDA’s current Good Manufacturing Practices. The drugmaker had previously called back its generic version of Lipitor pills in November 2012 for possibly containing small particles of glass. </p> <p>Soon after visiting the Toansa factory, the FDA banned the export of drug ingredients from the facility to the U.S. The Toansa ban means all four of its Indian plants have been banned from selling in the U.S. </p> <p><a href="http://www.bloomberg.com/news/2014-03-08/ranbaxy-recalls-generic-lipitor-in-u-s-after-dose-mix-up-found.html?cmpid=yhoo" title="http://www.bloomberg.com/news/2014-03-08/ranbaxy-recalls-generic-lipitor-in-u-s-after-dose-mix-up-found.html?cmpid=yhoo">http://www.bloomberg.com/news/2014-03-08/ranbaxy-recalls-generic-lipitor-in-u-s-after-dose-mix-up-found.html?cmpid=yhoo</a></p>

Ranbaxy Recall of Generic Lipitor: Dose Mix Up 20 Milligram Bottles Found To Contain 10 Milligram Does

The FDA upon their latest recent visit has pretty much stopped all exports of the drug or the active ingredient exports to the US and now a ...

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Ranbaxy faked test records: US FDA

<p> The center of the investigation is whether or not the proper amount of the active ingredient was contained in the product and if the shelf life had been properly labeled according to the standards set forth by the FDA.  There are efforts being made to group together on inspections with other countries as well.  Both Australia and the UK are also <strong><a href="http://ducknetweb.blogspot.com/2008/07/us-europe-australia-to-jointly-inspect.html">working with the FDA to jointly inspect drug factories</a></strong> in both China and India.  <img align="right" src="http://lh4.google.com/DucknetServices/R-UwKVKN8DI/AAAAAAAAEHA/33zLAhVEK5o/s144/fdaimage.png" /> </p> <p>The investigation process is in the process.  We already had the one nightmare in China in the news with the recent heparin story whereby an economic decision was slated to be at the room of the problem, and hopefully this is not another repeat in the same direction to keep costs down, and the manufacturer is fully cooperating with the FDA.  BD</p> <blockquote>The United States Food and Drugs Administration has filed a complaint against Indian drugmaker Ranbaxy Laboratories Ltd with a local court, saying that the quality of drugs made at one of its domestic plants is poor, according to a person familiar with the matter. Ranbaxy, however, defended itself saying the court has not initiated any proceedings against the company. "Ranbaxy strongly denies these allegations contained in the motion," said a company spokesperson.</blockquote> <div class="wlWriterSmartContent" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:c12b1ce5-7798-47eb-b9bf-c0a4ae61a947" style="padding-right: 0px; display: inline; padding-left: 0px; float: none; padding-bottom: 0px; margin: 0px; padding-top: 0px">del.icio.us Tags: <a href="http://del.icio.us/popular/FDA" rel="tag">FDA</a>,<a href="http://del.icio.us/popular/India" rel="tag">India</a>,<a href="http://del.icio.us/popular/Pharmaceuticals" rel="tag">Pharmaceuticals</a>,<a href="http://del.icio.us/popular/Ranbaxy" rel="tag">Ranbaxy</a>,<a href="http://del.icio.us/popular/Inspections" rel="tag">Inspections</a></div> <div class="wlWriterSmartContent" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:b8a6a59e-1688-430a-bb11-caa20fd77916" style="padding-right: 0px; display: inline; padding-left: 0px; float: none; padding-bottom: 0px; margin: 0px; padding-top: 0px">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/India" rel="tag">India</a>,<a href="http://technorati.com/tags/Pharmaceuticals" rel="tag">Pharmaceuticals</a>,<a href="http://technorati.com/tags/Ranbaxy" rel="tag">Ranbaxy</a>,<a href="http://technorati.com/tags/Inspections" rel="tag">Inspections</a></div> <p><a href="http://sify.com/finance/fullstory.php?id=14714706">Ranbaxy faked test records: US FDA</a></p>

Ranbaxy faked test records: US FDA

The center of the investigation is whether or not the proper amount of the active ingredient was contained in the product and if the shelf ...

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Teva and Ranbaxy Agreement Announced for the Sale of Generic Lipitor

<p>With the huge sales of Lipitor Pfizer has had over the years, this has to be one of the hottest generics around today as <a href="http://www.tevapharm.com/">Teva</a> will profit from a portion of the sales.  <img align="right" border="0" src="http://lh4.ggpht.com/--l6EAvQancw/TrmektrQPRI/AAAAAAAA4OE/DAYYXyON6uo/image_thumb.png?imgmax=800" style="background-image: none; border-bottom: 0px; border-left: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: right; border-top: 0px; border-right: 0px; padding-top: 0px" />Pfizer in the meantime said the would sell name brand Lipitor at the generic prices.  </p> <p>Earlier this month, Teva announced laying off over 100 employees in the US and the UK after acquiring Cephalon.  </p> <h4><a href="http://ducknetweb.blogspot.com/2011/11/teva-laying-off-over-1000-employees-in.html"><font size="2">Teva Laying Off Over 1000 Employees in the US and UK After Cephalon Acquisition</font></a></h4> <blockquote> <p>JERUSALEM--(<a href="http://www.businesswire.com/">BUSINESS WIRE</a>)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that pursuant to an agreement between its subsidiary, Teva Pharmaceuticals USA, Inc. and Ranbaxy Laboratories Limited ("Ranbaxy"), a portion of the profits from Ranbaxy’s sales of Atorvastatin Calcium Tablets during Ranbaxy’s 180-day first-to-file exclusivity period, will be paid to Teva. Terms of the agreement will not be disclosed. </p> <p>Atorvastatin Calcium Tablets are the generic version of Pfizer’s Lipitor® Tablets. Annual sales of Lipitor® were approximately $7.8 billion in the United States as of September 2011, based on IMS sales data. </p> </blockquote> <p><a href="http://www.businesswire.com/news/home/20111130006876/en/Teva-Announces-Agreement-Ranbaxy-Generic-Lipitor%C2%AE">http://www.businesswire.com/news/home/20111130006876/en/Teva-Announces-Agreement-Ranbaxy-Generic-Lipitor%C2%AE</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:db43786d-4917-4bf1-a2f9-2a1bccdfefcc" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Cephalon" rel="tag">Cephalon</a>,<a href="http://technorati.com/tags/Teva" rel="tag">Teva</a>,<a href="http://technorati.com/tags/mergers+and+acquistions" rel="tag">mergers and acquistions</a>,<a href="http://technorati.com/tags/pharma" rel="tag">pharma</a>,<a href="http://technorati.com/tags/drugs" rel="tag">drugs</a>,<a href="http://technorati.com/tags/mergers+and+acquisitions" rel="tag">mergers and acquisitions</a>,<a href="http://technorati.com/tags/layoffs" rel="tag">layoffs</a>,<a href="http://technorati.com/tags/Ranbaxy" rel="tag">Ranbaxy</a></div>

Teva and Ranbaxy Agreement Announced for the Sale of Generic Lipitor

With the huge sales of Lipitor Pfizer has had over the years, this has to be one of the hottest generics around today as Teva will profit f...

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Ranbaxy Recalling Generic Version of Lipitor–Small Particles of Glass Contamination Cites

<p>This is one of the biggest prescribed generic drugs out there as it was just last year that both Teva and Ranbaxy both announced the<img align="right" alt="image" border="0" height="102" src="http://lh6.ggpht.com/-V-5pdHul4_Q/ULLFR2mAcRI/AAAAAAABATI/XFciOspApfc/image%25255B4%25255D.png?imgmax=800" style="background-image: none; border-bottom: 0px; border-left: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: right; border-top: 0px; border-right: 0px; padding-top: 0px" title="image" width="152" /> immediate sale of their generic Lipitor formulas once the patent expire.   Almost 1 million generic prescriptions are written a week for one of the formulas, and that’s a lot of scripts so the lion’s share goes between both companies.  The drug is manufactured here in the US at a New Jersey plant.  Atorvastatin calcium is the generic name for the drug.  BD <br clear="all" /> <br clear="all" /></p> <h4><a href="http://ducknetweb.blogspot.com/2011/11/teva-and-ranbaxy-agreement-announced.html"><font size="2">Teva and Ranbaxy Agreement Announced for the Sale of Generic Lipitor</font></a> <hr /></h4> <p><a href="http://www.bloomberg.com/quote/RBXY:IN"> <br clear="all" />Ranbaxy Laboratories Ltd. (RBXY)</a> fell the most in more than<img align="right" alt="image" border="0" height="107" src="http://lh3.ggpht.com/-ehFTy_l8CJ0/ULLFSYa_NDI/AAAAAAABATQ/j7PwK9M3iXI/image%25255B11%25255D.png?imgmax=800" style="background-image: none; border-bottom: 0px; border-left: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: right; border-top: 0px; border-right: 0px; padding-top: 0px" title="image" width="89" /> three months after announcing a recall of the company’s generic version of <a href="http://www.bloomberg.com/quote/PFE:US">Pfizer Inc. (PFE)</a>’s cholesterol treatment Lipitor. </p> <p>Ranbaxy is pulling the pills from the U.S. because they may contain small particles of glass, the company said in a statement on its website. The recall of atorvastatin will cause a “temporary disruption” in the supply of the drug and it will take two weeks to complete an investigation into the issue, Ranbaxy said. <br clear="all" /> <br clear="all" />Ranbaxy, which was cleared by U.S. regulators to sell copies of the cholesterol pill last year, agreed to make changes at its manufacturing plants to settle allegations that its pharmaceuticals didn’t meet FDA standards, according to a proposed settlement filed by the <a href="http://topics.bloomberg.com/justice-department/">Justice Department</a> in January. The company announced on Dec. 21 that it had reached an agreement with the FDA and committed to tightening procedures and policies to comply with industry standards. </p>

Ranbaxy Recalling Generic Version of Lipitor–Small Particles of Glass Contamination Cites

This is one of the biggest prescribed generic drugs out there as it was just last year that both Teva and Ranbaxy both announced the immedi...

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Department of Justice drops legal action against India's Ranbaxy

<p> You can read the <a href="http://ducknetweb.blogspot.com/2008/07/drug-wars-fda-ranbaxy-department-of.html">history here.</a>  Additional Ranbaxy <a href="http://ducknetweb.blogspot.com/search?q=ranbaxy&x=0&y=0">posts can be accessed here.</a>  Good news for Ranbaxy but no mention on the FDA stance<img align="right" src="http://lh4.ggpht.com/DucknetServices/SIj9P_nkLTI/AAAAAAAAIV8/aMAtC1YcAlA/fda1_thumb[2].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /> yet.  BD  </p> <blockquote>The US Department of Justice said yesterday it had dropped legal action against Ranbaxy, the Indian generic drugs maker, after the group stepped up co-operation over regulators' concerns over its manufacturing. Ranbaxy's shares jumped almost 10 per  cent, having long been depressed by escalating investigations from the US Food and Drug Administration, triggering a ban which is still in place that stops the US importing or purchasing the company's drugs.</blockquote> <p><a href="http://www.ft.com/cms/s/47d04d86-959a-11dd-aedd-000077b07658,Authorised=false.html?_i_location=http%3A%2F%2Fwww.ft.com%2Fcms%2Fs%2F0%2F47d04d86-959a-11dd-aedd-000077b07658.html%3Fnclick_check%3D1&_i_referer=&nclick_check=1">FT.com / Home UK / UK - DoJ drops legal action against India's Ranbaxy</a></p>

Department of Justice drops legal action against India's Ranbaxy

You can read the history here.   Additional Ranbaxy posts can be accessed here.   Good news for Ranbaxy but no mention on the FDA stance y...

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In Two Days, Four New Drugs Stall at FDA

<p>Reports of four experimental drugs held up at the FDA emerged in the first two days of this week. “<em>There’s almost certainly a bit of coincidence at work here, but it also seems to be one more sign of the tough safety climate at the agency these </em><a href="http://blogs.wsj.com/health/2008/10/22/in-two-days-four-new-drugs-stall-at-fda/"><em><img align="right" src="http://lh4.ggpht.com/DucknetServices/SIj9P_nkLTI/AAAAAAAAIV8/aMAtC1YcAlA/fda1_thumb[2].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /></em></a><em>days</em>.”  Below are the 4 drugs.  No doubt the FDA is looking seriously at the side effects and studies and the new Sentinel system once it is up and running will be a big help for having additional data.  BD  </p> <p><strong>Milnacipran</strong></p> <p><strong>Asenapine</strong></p> <p><strong>Fablyn</strong></p> <p><strong>Vicodin</strong></p> <p>In other FDA news the Government Accountability Office is looking in to the Ranbaxy case, stating there were too many oversights and asking why this occurred.  I might guess part of the issue was due to a lack of technology for reporting purposes, which now the task is being undertaken to bring the FDA up to current standards to have the intelligence to stay on top of such.  BD  </p> <p><strong><u>Related Reading:</u></strong>  </p> <h4><a href="http://ducknetweb.blogspot.com/2008/10/us-fda-to-open-office-in-new-delhi.html">US FDA to open office in New Delhi, Mumbai</a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/10/department-of-justice-drops-legal.html">Department of Justice drops legal action against India's Ranbaxy</a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/09/ranbaxy-finds-rudy-giuliani-is-for-hire.html">Ranbaxy Finds Rudy Giuliani is for hire..</a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/09/fda-bans-import-of-meds-from-ranbaxy.html">FDA Bans Import of Meds From Ranbaxy</a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/07/ranbaxy-faked-test-records-us-fda.html">Ranbaxy faked test records: US FDA</a></h4> <p><a href="http://blogs.wsj.com/health/2008/10/22/in-two-days-four-new-drugs-stall-at-fda/">http://blogs.wsj.com/health/2008/10/22/in-two-days-four-new-drugs-stall-at-fda/</a></p> <div class="wlWriterEditableSmartContent" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:d5224db8-ac12-4acd-a1a4-4088c6c8bb50" style="padding-right: 0px; display: inline; padding-left: 0px; float: none; padding-bottom: 0px; margin: 0px; padding-top: 0px">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/Ranbaxy" rel="tag">Ranbaxy</a>,<a href="http://technorati.com/tags/Drug+Safety" rel="tag">Drug Safety</a>,<a href="http://technorati.com/tags/Drugs" rel="tag">Drugs</a>,<a href="http://technorati.com/tags/Pharma" rel="tag">Pharma</a>,<a href="http://technorati.com/tags/Medications" rel="tag">Medications</a></div>

In Two Days, Four New Drugs Stall at FDA

Reports of four experimental drugs held up at the FDA emerged in the first two days of this week. “ There’s almost certainly a bit of coinci...

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FDA comes under Congress scanner over Ranbaxy issue as well as the Department of Justice..

<p> Congress and the Department of Justice now join the inquiry about the FDA actions investigating the alleged falsification of test records.  This is where<strong> <a href="http://ducknetweb.blogspot.com/2008/07/us-europe-australia-to-jointly-inspect.html">joint committees</a></strong> could also stand to shed some light here as both Australia and the UK are working with the FDA in reference to drug factories in China and India.  As the Congressional investigation continues this certainly sets a real precedence to keep active inspections alive and going at all times as it stands to endanger the safety of lives with those taking the generic drugs.</p> <p>I certainly hope this is not the case,<strong> but the “<u>economic decisions”</u> of what <img align="right" src="http://lh4.google.com/DucknetServices/R-UwKVKN8DI/AAAAAAAAEHA/33zLAhVEK5o/s144/fdaimage.png" />happened in China with the Heparin scandal still remain fresh in my mind</strong> and I’m sure others may render the same feelings when it comes to drug safety.  BD  </p> <blockquote>NEW YORK: The US drug regulator FDA, which has charged Ranbaxy with selling unsafe medicines in the country, has come under the Congress  scanner and will be probed for its conduct in approving the Indian pharma major's products and other potential violations in the matter<strong>. A Congressional Committee has said that it would examine Ranbaxy's drug approvals in the US and potential violations of manufacturing regulations</strong>, a media report said. Besides, the House Energy and Commerce Committee would also "look at why the FDA continued to approve medicines made by the company and allow shipments into the US while it was questioning Ranbaxy's manufacturing processes," the Star Ledger newspaper reported.</blockquote> <div class="wlWriterSmartContent" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:4ac367a0-c702-4325-bba1-521f91e26ae3" style="padding-right: 0px; display: inline; padding-left: 0px; float: none; padding-bottom: 0px; margin: 0px; padding-top: 0px">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/Generic+Drugs" rel="tag">Generic Drugs</a>,<a href="http://technorati.com/tags/Pharma" rel="tag">Pharma</a>,<a href="http://technorati.com/tags/Congress" rel="tag">Congress</a></div> <p><a href="http://economictimes.indiatimes.com/Economy/USFDA_comes_under_Cong_scanner/articleshow/3245058.cms">FDA comes under Congress scanner over Ranbaxy issue- Policy-Economy-News-The Economic Times</a></p>

FDA comes under Congress scanner over Ranbaxy issue as well as the Department of Justice..

Congress and the Department of Justice now join the inquiry about the FDA actions investigating the alleged falsification of test records. ...

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Drug Wars – FDA, Ranbaxy, the Department Of Justice and Congress…

<p>The issues at hand goes back to 2006 with deviations from specifications on drugs, and now it is up to the Congress and the FDA once more.  Did <strong>the FDA knowingly allow suspected drugs to continue to be sold?</strong>  Ranbaxy makes a lot of different generic <img align="right" src="http://lh4.google.com/DucknetServices/R-UwKVKN8DI/AAAAAAAAEHA/33zLAhVEK5o/s144/fdaimage.png" /> drugs and there’s no mention of the ones in question.  This one could get hot depending on what the investigations return, federal agents raided the New Jersey plant earlier this year.  I just hope there’s not another “<strong>economic decision”</strong> somehow involved. I sure hope this is not a widespread condition.  BD     </p> <blockquote>The U.S. Department of Justice has accused $1.6 billion (sales) Ranbaxy Laboratories, India's largest pharmaceutical firm, <strong>of selling adulterated drugs. In a motion filed July 3 in federal court in Maryland</strong>, the Justice Department alleged that Ranbaxy, one of the world's biggest generic drug makers, has engaged in a "pattern of systematic fraudulent conduct," including false and fabricated information submitted to the Federal Drug Administration, as well as attempts to conceal from the FDA "violations of current good manufacturing practices regulations." <div class="wlWriterSmartContent" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:5660f4fa-1979-459e-9eaf-2b0cb2fdce40" style="padding-right: 0px; display: inline; padding-left: 0px; float: none; padding-bottom: 0px; margin: 0px; padding-top: 0px">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/Ranbaxy" rel="tag">Ranbaxy</a>,<a href="http://technorati.com/tags/Drugs" rel="tag">Drugs</a>,<a href="http://technorati.com/tags/Congress" rel="tag">Congress</a></div> </blockquote> <p><a href="http://www.forbes.com/healthcare/2008/07/18/ranbaxy-drugmaker-india-biz-healthcare-cz_mb_0718ranbaxy.html?feed=rss_business_healthcare">Drug Wars - Forbes.com</a></p>

Drug Wars – FDA, Ranbaxy, the Department Of Justice and Congress…

The issues at hand goes back to 2006 with deviations from specifications on drugs, and now it is up to the Congress and the FDA once more.  ...

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India Pharma Ranbaxy Fights FDA Charges

<p> The battle continues on but once the FDA opens offices in India, perhaps that will help out being close to the source to ensure safety and compliance.  Meanwhile Ranbaxy is business as usual with continuing to submit new drugs and information to the FDA, and they are the 15th largest producer of drugs in the world, however the US and Europe account for over 60% of the business, so a tainted name is not good.</p> <p>Now it appears Congress is a bit confused too over the investigation, why were the products still left on the market if there was a problem, good question anyone would want to know I think.  More growing pains for the FDA.  BD<img align="right" src="http://lh4.ggpht.com/DucknetServices/SIj9P_nkLTI/AAAAAAAAIV8/aMAtC1YcAlA/fda1_thumb[2].png?imgmax=800" /> </p> <blockquote> <p>For now, Ranbaxy continues to receive new approvals from the FDA for other drugs. For instance, it has negotiated 180-day exclusivity in the U.S. for generic versions of drugs that have a market size of more than $32 billion, including AstraZeneca's (AZN) Nexium. Singh says the company is making plans for what to do with its $800 million war chest and debt-free balance sheet, hinting at acquisitions both locally and internationally. "I clearly see the industry continuing to consolidate," he says. "We are just waiting for the transaction to close.&We expect to do something in the next year.</p> <p> "Unfortunately," wrote the two members of the House Energy & Commerce Committee, "the FDA's alleged lack of action to remove these suspected products from the market requires this committee to review the pre-market approval inspections of all currently marketed Ranbaxy drugs, as well as any 'for cause' inspections, to determine if [the] FDA has expended the resources required to justify leaving these suspect drugs on the market."</p> </blockquote> <p><a href="http://www.businessweek.com/globalbiz/content/sep2008/gb2008094_015006_page_2.htm">India Pharma Ranbaxy Fights FDA Charges</a></p>

India Pharma Ranbaxy Fights FDA Charges

The battle continues on but once the FDA opens offices in India, perhaps that will help out being close to the source to ensure safety and ...

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FDA Bans Import of Meds From Ranbaxy

<p> More can be <a href="http://ducknetweb.blogspot.com/2008/09/india-pharma-ranbaxy-fights-fda-charges.html">read here</a> as well.  The issue goes back to a raid in 2006 of a US warehouse in New Jersey.  If the pills were a problem, why were they allowed to continue to ship with allegations that factory test records were falsified.  Well I guess this now gives us the answer while the investigation continues that if there are potential issues a halt should take place until all the facts are found since the involvement of the Department of Justice.  BD</p> <p><a href="http://ducknetweb.blogspot.com/2008/07/fda-comes-under-congress-scanner-over.html">History:</a>  Congress and the Department of Justice now join the inquiry about the FDA actions investigating the alleged falsification of test records.  This is where<strong> <a href="http://ducknetweb.blogspot.com/2008/07/us-europe-australia-to-jointly-inspect.html">joint committees</a></strong> could also stand to shed some light here as both Australia and the UK are working with the FDA in reference to drug factories in China and India.  As the Congressional investigation continues this certainly sets a real precedence to keep active inspections alive and going at all times as it stands to endanger the safety of lives with those taking the generic drugs.<img align="right" src="http://lh4.ggpht.com/DucknetServices/SIj9P_nkLTI/AAAAAAAAIV8/aMAtC1YcAlA/fda1_thumb[2].png?imgmax=800" /> </p> <p>In a major drug safety alert, the Food and Drug Administration announced today that the U.S. can refuse to import dozens of generic drugs taken by millions of Americans that are made by a major drug manufacturer in India. </p> <p>The Food and Drug Administration announced Tuesday, Sept. 16, 2008, that the U.S. can refuse to import certain medications from Ranbaxy, a major manufacturer of generic drugs.</p> <p><strong>People taking any of 30 generic medications, such as the generics of Cipro, Alavert and Claritin, all made at two Ranbaxy plants in India, could be affected by today's alert.</strong> </p> <p>But the FDA said that drug shortages are not expected in the United States, because, in all instances except for one, <u>enough other suppliers can help meet demand for the medications.</u> </p> <p><a href="http://abcnews.go.com/Health/story?id=5814141&page=1">ABC News: FDA Bans Import of Meds From Major Drug Maker</a> </p> <div class="wlWriterSmartContent" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:d400be99-2b0a-47fe-85f9-b5b1cb1955a9" style="padding-right: 0px; display: inline; padding-left: 0px; padding-bottom: 0px; margin: 0px; padding-top: 0px">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/Ranbaxy" rel="tag">Ranbaxy</a>,<a href="http://technorati.com/tags/Drugs" rel="tag">Drugs</a>,<a href="http://technorati.com/tags/Generic%20Drugs" rel="tag">Generic Drugs</a></div>

FDA Bans Import of Meds From Ranbaxy

More can be read here as well.  The issue goes back to a raid in 2006 of a US warehouse in New Jersey.  If the pills were a problem, why w...

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Ranbaxy Finds Rudy Giuliani is for hire..

<p>The story keeps getting stranger by the day.  A little recent history can be <a href="http://ducknetweb.blogspot.com/2008/09/fda-bans-import-of-meds-from-ranbaxy.html">found here.</a>  The US is only 2-3% of their entire market so most pharmacies have already found other supplies, such as Walgreens did a few months ago when things started brewing.<strong>  </strong><a href="http://online.wsj.com/article/SB122167721431448665.html?mod=googlenews_wsj"><strong>Will this soon be a Japanese owned business?</strong></a>  The proposed purchase as stated below is not affected by the recent activities taking place in the US.  BD  </p> <p><em>“Japan's </em><a href="http://online.wsj.com/public/quotes/main.html?symbol=4568.to"><em>Daiichi Sankyo</em></a><em> Co., which is awaiting Indian government approval for its $4.6 billion bid for Ranbaxy, said the move won't affect the proposed deal. "We are implementing the [takeover] procedure as planned," a spokesman said.”</em></p> <p>The Indian generic drugmaker, which is under <a href="http://www.pharmalot.com/2008/07/ranbaxy-accused-by-feds-of-falsifying-records/">investigation</a> for allegedly falsifying records that resulted in the production and sale of generic meds that didn’t meet FDA standards, <strong>has hired Rudy Giuliani</strong> “to provide advice and review compliance issues,” according to <a href="http://www.pharmalot.com/wp-content/uploads/2008/09/ranbaxy-rudy.doc">a statement</a> this evening.</p> <p>This is the second time the former New York City mayor has acted as a paid consultant to a troubled drugmaker. <a href="http://www.pharmalot.com/2007/05/oxycontin_andour_next_presiden/">He also worked for Purdue Pharma</a>, which was fined for its Oxycontin marketing, and he helped negotiate a deal with federal prosecutors that kept company execs out of jail. Ironically, when he was a US Attorney in Manhattan, Rudy didn’t hesitate to send junk bond dealers to jail because they preyed on the system. Of course, Rudy is a private consultant now and paid to serve his clients.</p> <p><a href="http://www.pharmalot.com/2008/09/ranbaxy-hires-rudy-giuliani-to-fend-off-feds/">http://www.pharmalot.com/2008/09/ranbaxy-hires-rudy-giuliani-to-fend-off-feds/</a></p> <div class="wlWriterEditableSmartContent" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:99c8b10f-35a5-49ea-946c-e09a1bb8aef5" style="padding-right: 0px; display: inline; padding-left: 0px; float: none; padding-bottom: 0px; margin: 0px; padding-top: 0px">Technorati Tags: <a href="http://technorati.com/tags/Ranbaxy" rel="tag">Ranbaxy</a>,<a href="http://technorati.com/tags/generic+drugs" rel="tag">generic drugs</a>,<a href="http://technorati.com/tags/Guiliani" rel="tag">Guiliani</a>,<a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/Pharma" rel="tag">Pharma</a></div>

Ranbaxy Finds Rudy Giuliani is for hire..

The story keeps getting stranger by the day.  A little recent history can be found here.   The US is only 2-3% of their entire market so mos...

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Lipitor Goes Generic on 11/30/11

<p> There’s still a few years left, but time for Pfizer to focus on other research projects and of course  investing more in biotech industries.  Who knows where health care will be when Lipitor comes off the protected patent list and personalized medicine might even be more of a factor at that time as well.  BD </p> <blockquote>Start the countdown. On Nov. 30, 2011, Lipitor, the biggest selling drug of <a href="http://lh4.ggpht.com/DucknetServices/SFlNOcORosI/AAAAAAAAHsQ/yDVlq45Gf_E/s1600-h/image%5B3%5D.png"><img align="left" alt="image" border="0" height="117" src="http://lh4.ggpht.com/DucknetServices/SFlNPCGSBoI/AAAAAAAAHsU/85VIXG0BhnY/image_thumb%5B1%5D.png?imgmax=800" style="border-right: 0px; border-top: 0px; border-left: 0px; border-bottom: 0px" title="image" width="118" /></a>all time, will face generic competition. Pfizer, which sells the cholesterol drug, has been battling generics manufacturer Ranbaxy to protect the Lipitor cash cow for a few more years. Ranbaxy had been pushing to sell the drug in 2010, when the basic patent expires; Pfizer had argued that various other patents should keep the drug locked up until 2016. Now the companies have settled their legal fight an</blockquote> <p><a href="http://blogs.wsj.com/health/2008/06/18/countdown-to-expiry-lipitor-goes-generic-on-113011/">Health Blog : Countdown to Expiry: Lipitor Goes Generic on 11/30/11</a></p>

Lipitor Goes Generic on 11/30/11

There’s still a few years left, but time for Pfizer to focus on other research projects and of course  investing more in biotech industries...

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First-Time Generic Approvals: Focalin, Valtrex, Hydrodiuril

Medscape Medical News 2007. © 2007 Medscape<br /><br />February 16, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for dexmethylphenidate HCl tablets in the treatment of attention-deficit/hyperactivity disorder, valacyclovir HCl tablets for the treatment of genital herpes and shingles, and hydrochlorothiazide 12.5-mg tablets for the treatment of edema and hypertension.<br />Generic Dexmethylphenidate HCl Tablets (Focalin) for ADHD<br />On January 29, the FDA approved first-time generic 2.5-, 5-, and 10-mg formulations for dexmethylphenidate HCl tablets (made by Teva Pharmaceuticals USA; brand name Focalin, made by Novartis Pharmaceuticals Corp).<br />Dexmethylphenidate tablets are indicated for the treatment of attention-deficit/hyperactivity disorder in patients aged 6 to 17 years.<br />Generic Valacyclovir HCl Tablets (Valtrex) for Genital Herpes, Shingles<br />On January 31, the FDA approved first-time generic formulations for valacyclovir HCl 500-mg and 1-g tablets (made by Ranbaxy, Inc; brand name Valtrex, made by GlaxoSmithKline).<br />Valacyclovir is indicated for the treatment/suppression of genital herpes in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected patients. It also may be used for the treatment of herpes zoster (shingles).<br />Generic Hydrochlorothiazide 12.5-mg Tablets (Hydrodiuril) for Edema, Hypertension<br />On January 23, the FDA approved a first-time generic 12.5-mg formulation for hydrochlorothiazide (HCTZ) tablets (made by Mylan Pharmaceuticals, Inc; brand name Hydrodiuril, discontinued by Merck and Co, Inc).<br />The FDA notes that although generic formulations of HCTZ 12.5-mg capsules were previously approved, the current approval represents the first for generic tablets in this strength.<br />HCTZ is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy; and for use alone or with other agents for the management of hypertension. It has also been found useful for edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.<br />You may need to log in for the story below.<br /><a href="http://www.medscape.com/viewarticle/552375_print">http://www.medscape.com/viewarticle/552375_print</a><br /><a href="http://www.medscape.com/viewarticle/552375_print"></a>

First-Time Generic Approvals: Focalin, Valtrex, Hydrodiuril

Medscape Medical News 2007. © 2007 Medscape February 16, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic fo...

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The Melamine Nightmare Needs to be Fixed – Business Intelligence Could Help

<p><strong> Melamine, a chemical used as a flame retardant is used to make cooking utensils and industrial coatings, is rich in nitrogen; it makes an attractive low-cost additive to milk and other foods;  as nitrogen registers as protein on many routine tests</strong>. This is why it is so popular as at created the impression that the food contains much more protein than it really does. <img align="right" src="http://lh4.ggpht.com/_v3zjJigoAPE/SRnGVCBSiAI/AAAAAAAAJ38/WbfxT39zaZM/image_thumb[1].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /></p> <p><strong>I was speaking the other day to a contractor who does remodeling on kitchens, and yes the counters that go into modern day kitchens too have melamine,</strong> so I guess in a way it could make one think this is almost like munching on the kitchen counter, but also <strong>so durable that in China they are are also considering making bricks from the melamine to recycle,</strong> and then you think the chemical is making it in to our bodies through food products, pretty scary knowing that the product is added on purposes to show a high nutritional food value.  </p> <p>So once again, I will come back around to using technology, <strong>business intelligence to monitor the production of food products,</strong> and as we become more global, we can’t rely on trust unfortunately, anywhere.  When you stop and think about technology monitoring the contents of each lot and reporting both let’s say to the FDA here in the US, and to the local company, this would stand to keep many more honest when it is not as easy to trick the consumers.  Sure it will take some expense and effort to establish, but in reality this is something where every country could benefit, especially knowing what is going to be shipped before it ever takes place, along with labeling product properly with the country, state and city of origin, so recalls when needed can be accomplished before others become ill or die due to tainted food products.<strong>  A bank of servers and a little bit of high tech monitoring would need to be established, and after all, we have it today, so why not set up a practice of monitoring the world’s food suppliers, everyone would benefit.</strong></p> <p><strong><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html">Under further reading I went into a little more detail,</a></strong> and if we want to be assured of safe food products worldwide, a bit of<strong> business intelligence will help get the job done,</strong> along with scheduled and non-schedules on premise visits world wide with companies that are producing food products, otherwise we are at the risk of the company producing the products and of recent we are seeing how that is not only costing lives but also creating an environment of not knowing which food products and pharmaceuticals are safe and have been approved by the lot with computers spitting out a quality report to both the manufacturer and to monitoring agencies such as the US FDA and to other monitoring entities outside the US as well.  BD  <img align="left" src="http://lh4.ggpht.com/DucknetServices/SIj9P_nkLTI/AAAAAAAAIV8/aMAtC1YcAlA/fda1_thumb[2].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /> </p> <blockquote> <p>(AP) -- Li Xiaokai died of kidney failure on the old wooden bed in the family farmhouse, just before dawn on a drizzly Sept. 10. Her grandmother wrapped the 9-month-old in a wool blanket. Her father handed the body to village men for burial by a muddy creek. The doctors and family never knew why she got sick. A day later, state media reported that the type of infant formula she drank had been adulterated with an industrial chemical.</p> </blockquote> <p><a href="http://www.physorg.com/news145980387.html">Deaths uncounted in China's tainted milk scandal</a></p> <p><strong><u>Related Reading:</u></strong></p> <h4><a href="http://ducknetweb.blogspot.com/2008/11/mike-leavitt-and-fda-commissioner.html"><font size="1">Mike Leavitt and FDA Commissioner Andrew von Eschenbach go to China for consultations</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html"><font size="1">FDA to detain food shipments from China – Why not add some technology to the inspection processes?</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/11/china-wants-to-make-bricks-from-toxic.html"><font size="1">China wants to make bricks from toxic milk - melamine</font></a></h4> <h6><a href="http://ducknetweb.blogspot.com/2008/11/business-intelligence-for-fda-on-way.html">Business Intelligence for the FDA on the way</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html">FDA to detain food shipments from China – Why not add some technology to the inspection processes?</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/11/broken-agency-china-and-fda.html">A Broken Agency – China and the FDA</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/09/medicine-is-low-tech-business-clinical.html">Medicine is a Low Tech Business - Clinical Studies still done on paper too!</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/fda-will-open-inspection-office-in.html">FDA will open inspection office in China this year</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/chinese-drug-firm-recalls-all-injection.html">Chinese drug firm recalls all injection products after deaths</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/fda-tiny-bit-of-melamine-ok-in-most.html">FDA: Tiny Bit of Melamine OK in Most Foods But we Still need better labeling and shipping documentation</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/09/fda-bans-import-of-meds-from-ranbaxy.html">FDA Bans Import of Meds From Ranbaxy</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/04/fda-head-we-boosting-it.html">FDA Head: We're Boosting I.T.</a></h6> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:608b7091-59c0-4dac-a687-1ff40dae53b5" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/China" rel="tag">China</a>,<a href="http://technorati.com/tags/phamaceutical+plant+inspections" rel="tag">phamaceutical plant inspections</a>,<a href="http://technorati.com/tags/FDA+funding" rel="tag">FDA funding</a>,<a href="http://technorati.com/tags/Congress+Pharma" rel="tag">Congress Pharma</a>,<a href="http://technorati.com/tags/Melamine" rel="tag">Melamine</a>,<a href="http://technorati.com/tags/Tainted+Milk" rel="tag">Tainted Milk</a>,<a href="http://technorati.com/tags/Food+Products" rel="tag">Food Products</a>,<a href="http://technorati.com/tags/Business+Intelligence" rel="tag">Business Intelligence</a></div>

The Melamine Nightmare Needs to be Fixed – Business Intelligence Could Help

Melamine, a chemical used as a flame retardant is used to make cooking utensils and industrial coatings, is rich in nitrogen; it makes an a...

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Drug Deals – Nexium and Teva Purple Pill Agreement, And What Is This Costing Us?

<p>The cost of the purple pill is enough to give one heartburn. Consumer reports is trying to help you out with some affordable over the counter alternatives.  Astra <a href="http://lh3.ggpht.com/_v3zjJigoAPE/S1NruV--y_I/AAAAAAAAcGk/ETf5_OSbSTs/s1600-h/image%5B3%5D.png"><img align="right" alt="image" border="0" height="139" src="http://lh3.ggpht.com/_v3zjJigoAPE/S1Nru1zklOI/AAAAAAAAcGo/0WhCquRHHV0/image_thumb%5B1%5D.png?imgmax=800" style="border-bottom: 0px; border-left: 0px; display: inline; margin-left: 0px; border-top: 0px; margin-right: 0px; border-right: 0px" title="image" width="143" /></a>Zeneca already cut a deal with Ranbaxy to delay it’s release of a generic version of the drug.  Who’s on the list for the next deal I wonder?  The drug is the biggest seller for Astra Zeneca too, and we have all seen the massive TV commercial media on how it is effective, there’s been a ton of marketing done here to equate everyone with “the purple pill”.   Interesting too in this survey that Nexium made the list of 8 drugs doctors wouldn’t take themselves…hmmmmm. </p> <p><a href="http://ducknetweb.blogspot.com/2008/06/8-drugs-doctors-wouldn-take.html">8 drugs doctors wouldn't take</a></p> <p><a href="http://www.tevapharm.com/">Teva</a> made an agreement here to pay off Astra Zeneca so they could continue to market a generic version of Prilosec, but on the Purple Pill issue they will have to hold off until 2014.  Teva if you have not kept up is a generic drug company from Israel that has been very aggressive in promoting and getting cheaper generic drugs to the market place.  </p> <h4><a href="http://ducknetweb.blogspot.com/2009/11/generic-prevacid-solutab-is-here-teva.html"><font size="2">Generic Prevacid SoluTab Is Here – Teva Wins Court Battle on Patent Challenge For Heartburn Drug</font></a></h4> <p>The latest report shows that only 22% of the drugs being prescribed in the US are generic, think some of these drug deals might have some influence here?  This is part of what healthcare reform is trying to eliminate enough to where this is a potential anti-trust issue for the FTC.  You know I could care less if I see any more drug ads on television as I know they are part of the area that continues to increase the price of what we pay in the US for our medications.  The drug companies could save a ton if they relied on the internet and save us from all the suggestive commercial we see all the time.  They are all just about sounding the same these days.  BD </p> <h4><a href="http://ducknetweb.blogspot.com/2010/01/generic-drug-deals-one-more-area-being.html"><font size="2">Generic Drug Deals – One More Area Being Explored to Help Reduce Cost of Healthcare by the FTC</font></a></h4> <p> <embed src="http://c.brightcove.com/services/viewer/federated_f8/1078549944" bgcolor="#FFFFFF" flashVars="videoId=46419015001&useOverlayMenu=false&playerId=1078549944&viewerSecureGatewayURL=https://console.brightcove.com/services/amfgateway&servicesURL=http://services.brightcove.com/services&cdnURL=http://admin.brightcove.com&domain=embed&autoStart=false&" base="http://admin.brightcove.com" name="flashObj" width="340" height="249" seamlesstabbing="false" type="application/x-shockwave-flash" swLiveConnect="true" pluginspage="http://www.macromedia.com/shockwave/download/index.cgi?P1_Prod_Version=ShockwaveFlash"></embed></p> <blockquote> <p>The heartburn drug Nexium is one of the most expensive of its kind, and that’s just the way the manufacturer, AstraZeneca, wants to keep it. The company said Thursday it inked <a href="http://www.astrazeneca.com/media/latest-press-releases/AZ-teva-agreement?itemId=8017085">a deal with Teva</a> shielding the lucrative <a href="http://www.consumerreports.org/health/prescription-drugs/esomeprazole/how-is-it-used.htm">esomeprazole</a> (Nexium) from generic competition until 2014. Nexium falls into a class of drugs called proton pump inhibitors that are used to treat <a href="http://www.consumerreports.org/health/conditions-and-treatments/gerd-in-adults/what-is-it.htm">severe heartburn and gastroesophageal reflux disease</a>, or GERD. </p> <p>Generic drugs cost significantly less and save consumers billions of dollars per year, but they can’t be sold until the patent expires on the brand-name drug, usually some 10 to 14 years after they first hit the market. And brand-name manufacturers may try to <a href="http://blogs.consumerreports.org/health/2009/02/whats-stalling-generic-drugs-.html">delay a generic drug’s availability</a> even longer by making deals with generic companies, basically by paying them to not manufacture the drug. Clearly, both drug manufacturers benefit from these arrangements, but it’s consumers who lose out.</p> </blockquote> <p><a href="http://blogs.consumerreports.org/health/2010/01/nexium-drugs-to-treat-heartburn-and-gastroesophageal-reflux-disease-astrazeneca-deal-with-teva.html">Consumer Reports Health Blog: Deal over heartburn drug is enough to give you, well, heartburn</a></p> <p></p> <p></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:4572b962-8299-4fbf-b2b9-4ca5368133b7" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://www.example.com/heartburn" rel="tag">heartburn</a>, <a href="http://www.example.com/purple+pill" rel="tag">purple pill</a>, <a href="http://www.example.com/Nexium" rel="tag">Nexium</a>, <a href="http://www.example.com/Teva" rel="tag">Teva</a>, <a href="http://www.example.com/drug+deals" rel="tag">drug deals</a>, <a href="http://www.example.com/Astra+Zenaca" rel="tag">Astra Zenaca</a>, <a href="http://www.example.com/FDA" rel="tag">FDA</a>, <a href="http://www.example.com/healthcare+reform" rel="tag">healthcare reform</a>, <a href="http://www.example.com/FTC" rel="tag">FTC</a>, <a href="http://www.example.com/generic+drugs" rel="tag">generic drugs</a>, <a href="http://www.example.com/GERD" rel="tag">GERD</a></div>

Drug Deals – Nexium and Teva Purple Pill Agreement, And What Is This Costing Us?

The cost of the purple pill is enough to give one heartburn. Consumer reports is trying to help you out with some affordable over the counte...

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FDA OKs Generic Ambien

<p> </p> <blockquote>The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals, TEVA Pharmaceuticals USA, Roxane Laboratories, Watson Laboratories, Ranbaxy Laboratories, Dr. Reddy’s Laboratories, Apotex, Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical Company, Caraco Pharmaceutical Laboratories, Carlsbad Technology, and Lek Pharmaceuticals.</blockquote> <p>Source: <a href="http://www.medicinenet.com/script/main/art.asp?articlekey=80647">FDA OKs Generic Ambien - Sleep Disorders including, Sleep Apnea, Narcolepsy, Insomnia, Snoring and Nightmares</a></p>

FDA OKs Generic Ambien

  The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals, TEVA Pharmaceuticals USA,...

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What’s in a Drug Patent for Pfizer – There are several Court Cases are Challenging Others Too

<p> The latest battle is with Pfizer and Mylan, a generic drug manufacturer going to court.  Mylan is ready to go to market but not until Pfizer gives the <a href="http://lh6.ggpht.com/_v3zjJigoAPE/SjdCeHXyZDI/AAAAAAAAQOM/JaRzPAaFe5s/s1600-h/image%5B3%5D.png"><img align="right" alt="image" border="0" height="146" src="http://lh6.ggpht.com/_v3zjJigoAPE/SjdCflpIUII/AAAAAAAAQOQ/LHIqu4iIhso/image_thumb%5B1%5D.png?imgmax=800" style="border-bottom: 0px; border-left: 0px; display: inline; margin-left: 0px; border-top: 0px; margin-right: 0px; border-right: 0px" title="image" width="205" /></a>go ahead and that date is in the year 2017.  Pfizer is not the only one being challenged by any means, <a href="http://www.merck.com/">Merck</a> has their issues with Singulair and <a href="http://www.tevapharm.com/">Teva</a> <a href="http://ducknetweb.blogspot.com/2009/02/merck-and-teva-go-to-court-over.html">challenging their patent,</a> so I ask what’s in a patent or intellectual property these days?  Here’s a short lists of expiring patents of some of the major drugs.  As you can see Lipitor is on the list for 2010 and Pfizer wants to extend that date a few years, like 6 more while they find their own sources to create a generic version.  </p> <p><b><u>2010 <br /></u></b>Pfizer's Lipitor, which is presently the best selling drug in the world with close to $12 billion in sales. <br />Wyeth's Effexor/XR which had $2.7 billion in peak U.S. sales. </p> <p><b><u>2011 <br /></u></b>Bristol Myers/Sanofi's Plavix which had $5 billion in peak U.S. sales <br />Lilly/Takeda/Watson's Actos which had $4.4 billion in peak U.S. sales <br />Lilly's Zyprexis which had $2.6 billion in peak U.S. sales </p> <p><b><u>2012 <br /></u></b>AstraZeneca's Seroquel which had $4.4 billion in peak U.S. sales <br />Merck's Singular/AR which had $3.4 billion in peak U.S. sales. </p> <h6><font size="2">Here’s a related post about Merck in a similar legal battle:  </font><a href="http://ducknetweb.blogspot.com/2009/02/merck-and-teva-go-to-court-over.html"><font size="2">Merck and Teva Go to Court over Singulair Going Generic</font></a></h6> <p>The battle has only begun and the biosimilar drugs battle is yet to come.  BD  </p> <h4><a href="http://ducknetweb.blogspot.com/2009/03/here-come-bio-similar-drugs-bill-in.html"><font size="2">Here Come the Bio Similar Drugs – Bill in Congress to allow Follow Me Provisions for the FDA</font></a></h4> <blockquote> <p>June 15 (Bloomberg) -- <a href="http://www.bloomberg.com/apps/quote?ticker=PFE%3AUS">Pfizer Inc.</a>, the world’s biggest drugmaker, sued rival <a href="http://www.bloomberg.com/apps/quote?ticker=MYL%3AUS">Mylan Inc.</a> asking a  judge to prohibit sales of a generic version of its cholesterol-fighting medicine Lipitor until 2017. </p> <p>In federal court papers filed today in Wilmington, Delaware, lawyers for New York-based Pfizer contend a Mylan affiliate has applied to the U.S. Food and Drug Administration for permission to sell copies of Lipitor, the world’s best- selling drug, before three Pfizer patents expire. <a href="http://www.bloomberg.com/apps/quote?ticker=RBXY%3AIN">Ranbaxy Laboratories Ltd.</a>, India’s biggest drugmaker and majority owned by Japan’s <a href="http://www.bloomberg.com/apps/quote?ticker=4568%3AJP">Daiichi Sankyo Co.</a>, settled a lawsuit filed by Pfizer and plans to enter the market in November 2011. Pfizer already is suing Apotex Inc. and <a href="http://www.bloomberg.com/apps/quote?ticker=TEVA%3AIT">Teva Pharmaceutical Industries Ltd.</a> to prevent them from selling copies of the medicine before then.</p> </blockquote> <p><a href="http://www.bloomberg.com/apps/news?pid=20601202&sid=aQBBXARr1PsY">Pfizer Sues Mylan Over Patents for Top-Drug Lipitor (Update2) - Bloomberg.com</a></p> <p></p> <p></p> <p><strong><u>Related Reading:</u></strong></p> <h6><a href="http://ducknetweb.blogspot.com/2009/06/microsoft-acquires-rosetta-biosoftware.html">Microsoft Acquires Rosetta Biosoftware – Merck Becomes Microsoft Life Sciences Client</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2009/02/merck-purchases-insmed-biosimilar.html">Merck Purchases Insmed – Biosimilar Biotech Drug Company</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2009/05/merck-issues-statement-on-singulair.html">Merck Issues Statement on Singulair Patent Challenge from Teva</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2009/02/merck-and-teva-go-to-court-over.html">Merck and Teva Go to Court over Singulair Going Generic</a></h6> <h4><a href="http://ducknetweb.blogspot.com/2009/03/generic-biotech-drugs-discussed-in.html"><font size="1">Generic biotech drugs discussed in Congress – Bio Similars</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2009/03/pfizer-inks-deal-to-sell-more-generics.html"><font size="1">Pfizer Inks Deal to Sell More Generics – From Aurobindo Pharma in India</font></a></h4> <h6><a href="http://ducknetweb.blogspot.com/2008/11/fda-approves-toviaz-distributed-by.html">FDA approves Toviaz - distributed by Pfizer, manufactured by Schwarz Pharma – Over Active Bladder</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/pfizer-joins-generic-club.html">Pfizer Joins the Generic Club</a></h6> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:4ac88928-9b20-4b02-9f85-0e509992082c" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Pfizer" rel="tag">Pfizer</a>,<a href="http://technorati.com/tags/Merck" rel="tag">Merck</a>,<a href="http://technorati.com/tags/Pharma" rel="tag">Pharma</a>,<a href="http://technorati.com/tags/drugs" rel="tag">drugs</a>,<a href="http://technorati.com/tags/Teva" rel="tag">Teva</a>,<a href="http://technorati.com/tags/Mylan" rel="tag">Mylan</a>,<a href="http://technorati.com/tags/patents" rel="tag">patents</a>,<a href="http://technorati.com/tags/intilectual+property" rel="tag">intilectual property</a>,<a href="http://technorati.com/tags/healthcare" rel="tag">healthcare</a>,<a href="http://technorati.com/tags/court+case" rel="tag">court case</a>,<a href="http://technorati.com/tags/follow+me+drugs" rel="tag">follow me drugs</a>,<a href="http://technorati.com/tags/biosimilars" rel="tag">biosimilars</a>,<a href="http://technorati.com/tags/generic+drugs" rel="tag">generic drugs</a></div>

What’s in a Drug Patent for Pfizer – There are several Court Cases are Challenging Others Too

The latest battle is with Pfizer and Mylan, a generic drug manufacturer going to court.  Mylan is ready to go to market but not until Pfize...

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Acid Inhibitors Like Nexium, Prilosec, Prevacid and Protonix Prolonged Use – FDA Says Watch It With Prolonged Use

<p> Bone fractures are the big call item here and it seems the longer the product is used, the greater the potential exposure would be.  The purple pills is kind of expensive too.  You can read more at the link about the marketing and prescribing news on the purple pill.  </p> <h4><a href="http://ducknetweb.blogspot.com/2010/01/drug-deals-nexium-and-teva-purple-pill.html"><font size="2">Drug Deals – Nexium and Teva Purple Pill Agreement, And What Is This Costing Us?</font></a></h4> <p>Consumer reports is trying to help you out with some affordable over the counter alternatives.  Astra <a href="http://lh3.ggpht.com/_v3zjJigoAPE/S1NruV--y_I/AAAAAAAAcGk/ETf5_OSbSTs/s1600-h/image%5B3%5D.png"><img align="right" alt="image" border="0" height="139" src="http://lh3.ggpht.com/_v3zjJigoAPE/S1Nru1zklOI/AAAAAAAAcGo/0WhCquRHHV0/image_thumb%5B1%5D.png?imgmax=800" title="image" width="143" /></a>Zeneca already cut a deal with Ranbaxy to delay it’s release of a generic version of the drug.  Who’s on the list for the next deal I wonder?  The drug is the biggest seller for Astra Zeneca too, and we have all seen the massive TV commercial media on how it is effective, there’s been a ton of marketing done here to equate everyone with “the purple pill”.   Interesting too in this survey that Nexium made the list of 8 drugs doctors wouldn’t take themselves…hmmmmm. </p> <p><strong>There are some other alternatives for GERD though, like surgery and devices.</strong></p> <h4><a href="http://ducknetweb.blogspot.com/2010/05/incisionless-surgery-for-gerd-through.html"><font size="2">Incisionless Surgery for GERD Through the Mouth Performed on First Patient at Scripps – Acid Reflux Fixed</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2010/04/torax-medical-gerd-implant-device-is.html"><font size="2">Torax Medical GERD Implant Device is Granted European CE Mark Approval – Trials in US Continue</font></a></h4> <p>If you are one that has chronic GERD, maybe looking into these areas might be worthwhile as this is where the FDA notice seems to be placed, on prolonged and frequent use.  BD  </p> <blockquote> <p>The Food and Drug Administration cautioned Tuesday against prolonged use or high dosages of the family of acid reducers called proton pump inhibitors, a family that includes such well-known drugs as <strong>Nexium, Prilosec, Prevacid and Protonix.</strong> The agency said it would order revised labeling on packages of the drugs to reflect the fact that they have been associated with an increased risk of fractures of the hip, wrist and spine.<a href="http://lh5.ggpht.com/_v3zjJigoAPE/S_x1esX-dhI/AAAAAAAAeTw/GhbzppliMz4/s1600-h/image%5B3%5D.png"><img align="right" alt="image" border="0" height="162" src="http://lh4.ggpht.com/_v3zjJigoAPE/S_x1fQMWPzI/AAAAAAAAeT0/SWNnBkFCEkY/image_thumb%5B1%5D.png?imgmax=800" style="border-bottom: 0px; border-left: 0px; display: inline; margin-left: 0px; border-top: 0px; margin-right: 0px; border-right: 0px" title="image" width="240" /></a> </p> <p>Other drugs in the family include Losec, Zegerid, Aciphex and omeprazole. An estimated 113.4 million prescriptions for the drugs are written each year and large numbers are sold over the counter.</p> <p>The drugs block the production of acid in the stomach and provide important benefits for many people with conditions such as erosive esophagitis, nonsteroidal anti-inflammatory drug-induced ulcers and gastroesophageal reflux disease. But most people take them primarily to control heartburn.</p> <p><strong>Two newer drugs, esomeprazole and dexlansoprazole are now being evaluated specifically for their effects on bone and results are expected by the end of 2011.</strong></p> </blockquote> <p><a href="http://latimesblogs.latimes.com/booster_shots/2010/05/the-fda-cautions-against-high-doseages-or-prolonged-use-of-acid-inhibitors.html">The FDA cautions against high dosages or prolonged use of acid inhibitors | Booster Shots | Los Angeles Times</a></p> <p></p> <p></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:62b4c963-f092-4e5a-bcb9-e93e2b040f45" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://www.example.com/Nexium" rel="tag">Nexium</a>, <a href="http://www.example.com/Prilosec" rel="tag">Prilosec</a>, <a href="http://www.example.com/Prevacid" rel="tag">Prevacid</a>, <a href="http://www.example.com/FDA" rel="tag">FDA</a>, <a href="http://www.example.com/warning+letters" rel="tag">warning letters</a>, <a href="http://www.example.com/calcium" rel="tag">calcium</a>, <a href="http://www.example.com/healthcare" rel="tag">healthcare</a>, <a href="http://www.example.com/drugs" rel="tag">drugs</a>, <a href="http://www.example.com/safety" rel="tag">safety</a>, <a href="http://www.example.com/GERD" rel="tag">GERD</a>, <a href="http://www.example.com/acid+reflux" rel="tag">acid reflux</a>, <a href="http://www.example.com/Protonix" rel="tag">Protonix</a></div>

Acid Inhibitors Like Nexium, Prilosec, Prevacid and Protonix Prolonged Use – FDA Says Watch It With Prolonged Use

Bone fractures are the big call item here and it seems the longer the product is used, the greater the potential exposure would be.  The pu...

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