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K-V Pharmaceutical Company Updates Status of New Drug Application for Gestiva™
Date:1/12/2011

ween the Company and the U.S. Department of Justice and the Company's obligations therewith, as well as the related material adverse effect, if any, on its revenue, assets and liquidity and capital resources, as more fully described in Item 1—"Business—(b) Significant Recent Developments—Plea Agreement with the U.S. Department of Justice" in the Form 10-K for fiscal 2010;

(11)  changes in the current and future business environment, including interest rates and capital and consumer spending;

(12)  the availability of raw materials and/or products manufactured for the Company under contract manufacturing agreements with third parties;

(13)  the regulatory environment, including regulatory agency and judicial actions and changes in applicable laws or regulations, including the risk of obtaining necessary state licenses in a timely manner;

(14)  fluctuations in revenues;

(15)  the difficulty of predicting the pattern of inventory movements by the Company's customers;

(16)  he impact of competitive response to the Company's sales, marketing and strategic efforts, including introduction or potential introduction of generic or competing products against products sold by the Company and its subsidiaries, including Gestiva™, and including competitive pricing changes;

(17)  risks that the Company may not ultimately prevail in litigation, including product liability lawsuits and challenges to its intellectual property rights by actual or potential competitors or to its ability to market generic products due to brand company patents and challenges to other companies' introduction or potential introduction of generic or competing products by third parties against products sold by the Company or its subsidiaries including without limitation the litigation and claims referred to in Note 15 – "Commitments and Contingencies" of the Notes to the Consolidated Financial St
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SOURCE K-V Pharmaceutical Company
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