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KV Provides Update on Gestiva(TM) PDUFA Date
Date:10/20/2008

regulatory environment, including regulatory agency and judicial actions and changes in applicable law or regulations; (9) fluctuations in revenues; (10) the difficulty of predicting international regulatory approval, including timing; (11) the difficulty of predicting the pattern of inventory movements by the Company's customers; (12) the impact of competitive response to the Company's sales, marketing and strategic efforts, including the introduction or potential introduction of generic or competing products against products sold by the Company and its subsidiaries; (13) risks that the Company may not ultimately prevail in litigation, including challenges to our intellectual property rights by actual or potential competitors or to our 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 16 of the Notes to the Consolidated Financial Statements in the Company's Form 10-Q for the quarter ended June 30, 2008; (14) actions by the Internal Revenue Service with respect to the Company's stock option grants and accounting practices; (15) the possibility that KV's current estimates of the financial effect of certain previously announced product recalls could prove to be incorrect; (16) whether any product recalls or product introductions results in litigation, agency action or material damages; (17) the possibility that the findings of the Audit Committee inquiry referenced in the Company's Form 10-Q for the quarter ended June 30, 2008, could have a material impact on the Company's financial results; (18) the satisfaction or waiver of the other closing conditions in the Gestiva(TM) acquisition agreement in addition to those noted above; and (19) the risks detailed from time-to-time in the Company's filings with
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