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K-V Pharmaceutical Announces Resubmission to New Drug Application for Gestiva™
Date:7/13/2010

and demand for the Company's new pharmaceutical products;
  • the introduction and impact of competitive products and pricing, including as a result of so-called authorized generic drugs or compounded 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;
  • the 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;
  • 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 18 – "Commitments and Contingencies" of the Notes to the Consolidated Financial Statements in the Form 10-Q;
  • the possibility that our current estimates of the financial effect of certain announced product recalls could prove to be incorrect;
  • whether any product recalls or product introductions result in litigation, agency action or m
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  • SOURCE K-V Pharmaceutical Company
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