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KV Pharmaceutical Reaches Agreement with U.S. Department of Justice
Date:2/25/2010

e normalized business operations at KV, regain full regulatory and legal compliance and set KV on a new path moving forward," said David Van Vliet, interim CEO of KV Pharmaceutical. "Management and the Board have been working diligently to address this issue and we are looking forward to having this matter resolved. Looking ahead, we remain focused on working alongside the FDA in accordance with our consent decree and demonstrating cGMP compliance so we can resume manufacturing and return our products to market."

Terry Hatfield, Chairman of the Board of Directors stated, "David Van Vliet and his management team assumed leadership of KV under difficult circumstances and during a critical period for the Company. The Board recognizes the commitment and focus David and his team have demonstrated as KV works towards rectifying prior regulatory and compliance issues and returning the Company to market."

Under the terms of the settlement, ETHEX's payment of $25.8 million includes $2.3 million in restitution to the federal government. The amounts would be paid through a pre-determined schedule running through July 2012.  ETHEX will plead guilty to two felony counts of failure in 2008 to file Field Alerts for the drugs Dextroamphetamine and Propafenone. In light of the plea and likely exclusion of ETHEX from government programs, the company has determined to cease operations
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SOURCE KV Pharmaceutical Company
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