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K-V Pharmaceutical Company Announces Completion of U.S. Food and Drug Administration Inspection and Approval to Return its First Product to Market
Date:9/10/2010

roved products to market in order to maintain and attempt to increase its limited cash and financial resources, and related costs and accounting charges from taking such actions;
  • the plea agreement between 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 Note 20 – "Subsequent Events" of the Notes to the Consolidated Financial Statements in the Form 10-Q;
  • changes in the current and future business environment, including interest rates and capital and consumer spending;
  • the difficulty of predicting FDA approvals, including timing, and that any period of exclusivity may not be realized;
  • the possibility of not obtaining FDA approvals or delay in obtaining FDA approvals, including with respect to Gestiva™, as well as the number of preterm births for which Gestiva™ may be prescribed, its safety profile and side effects profile;
  • acceptance of and demand for the Company's new pharmaceutical products or current products upon their return to the marketplace;
  • the introduction and impact of competitive products and pricing, including as a result of so-called authorized generic drugs;
  • new product development and launch, including the possibility that any product launch may be delayed;
  • reliance on key strategic acquisitions;
  • the availability of raw materials and/or products manufactured for the Company under contract manufacturing agreements with third parties;
  • the regulatory environment, including regulatory agency and judicial actions and changes in applicable laws or regulations;
  • fluctuations in revenues;
  • the difficulty of predicting international regulatory approvals, including timing;
  • the difficulty of predicting the pattern of inventory movements by the Company's customers;'/>"/>

  • SOURCE K-V Pharmaceutical Company
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