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KV Pharmaceutical Enters Into Consent Decree With FDA

Mon, 03/02/2009 - 4:28am
KV Pharmaceutical Company has entered into a consent decree withthe FDA regarding the company's drugmanufacturing and distribution. The decree provides a series of measuresthat, when satisfied, will permit KV to resume the manufacture anddistribution of products marketed by its subsidiaries, ETHEX and Ther-Rx. TheCompany is working expeditiously to satisfy the requirements and expects toprovide further information in upcoming communications. As part of the consent decree, KV has agreed not to market products itmanufactures until it has satisfied certain requirements designed todemonstrate compliance with FDA's current good manufacturing practices (CGMP)regulations. KV has also agreed that it will not distribute certain products,including its prenatal vitamins and hematinic products, until the products areapproved by FDA's ANDA or NDA processes. "We have been working diligently with the FDA for the last two months toreach agreement on a clear path forward to permit KV to resume manufacturingand marketing its products," said David A. Van Vliet, KV's Interim ChiefExecutive Officer. "Since December, when new management took over at KV, ourteam has taken significant steps to enhance our systems and procedures, and wewill continue to do so. We look forward to cooperating with the FDA duringthis process that will facilitate our return to the market. Predicting thetiming for the return and the ultimate product assortment that we will marketare presently very difficult due to the range of variables that must bemanaged. As we gain certainty, we will notify customers and all otherstakeholders." The consent decree provides that, before resuming manufacturing, KV willhave an independent third party CGMP expert consultant undertake a review ofKV's facilities and certify compliance with FDA's CGMP regulations. Followingthat certification, FDA will make a determination as to whether the KVfacilities are in compliance. The decree further provides that KV may requestof FDA that it be permitted to resume manufacturing and distribution ofcertain products before the company is cleared by FDA to resume fulloperations. KV has already retained the third party CGMP expert consultant,which has been on-site for several weeks. The consent decree is expected to be submitted today to the U.S. DistrictCourt, Eastern District of Missouri, Eastern Division by the Department ofJustice and is subject to approval by the Court.
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