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KV Pharmaceutical Enters Into Consent Decree With FDA
Date:3/2/2009

Decree outlines path forward to resume manufacturing at KV facilities

ST. LOUIS, March 2 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb) today announced that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company's drug manufacturing and distribution. The decree provides a series of measures that, when satisfied, will permit KV to resume the manufacture and distribution of products marketed by its subsidiaries, ETHEX and Ther-Rx. The Company is working expeditiously to satisfy the requirements and expects to provide further information in upcoming communications.

As part of the consent decree, KV has agreed not to market products it manufactures until it has satisfied certain requirements designed to demonstrate 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 are approved by FDA's ANDA or NDA processes.

"We have been working diligently with the FDA for the last two months to reach agreement on a clear path forward to permit KV to resume manufacturing and marketing its products," said David A. Van Vliet, KV's Interim Chief Executive Officer. "Since December, when new management took over at KV, our team has taken significant steps to enhance our systems and procedures, and we will continue to do so. We look forward to cooperating with the FDA during this process that will facilitate our return to the market. Predicting the timing for the return and the ultimate product assortment that we will market are presently very difficult due to the range of variables that must be managed. As we gain certainty, we will notify customers and all other stakeholders."

The consent decree provides that, before resuming manufacturing, KV will have an independent thir
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SOURCE KV Pharmaceutical Company
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