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K-V Pharmaceutical Company Announces Comprehensive Patient Assistance Program for Makena™
Date:3/8/2011

ing Makena™, and for our current products upon their return to the marketplace, as well as the number of preterm births for which Makena™ may be prescribed and its safety profile and side effects profile;
  • the possibility that any period of exclusivity may not be realized, including with respect to Makena™, a designated Orphan Drug;
  • the satisfaction or waiver of the terms and conditions for the acquisition and continued ownership of the full U.S. and worldwide rights to Makena™ set forth in the previously disclosed Makena™ acquisition agreement, as amended;
  • the consent decree between the Company and the U.S. Food and Drug Administration ("FDA") and the Company's suspension of the production and shipment of all of the products that it manufactures (other than the Potassium Chloride ER Capsule products that are the subject of the FDA letter received September 8, 2010 allowing the return of those products to the marketplace) and the related nationwide recall affecting all of the other products that it manufactures, as well as the related material adverse effect on its revenue, assets and liquidity and capital resources, as more fully described in Item 1—"Business—(b) Significant Recent Developments—Discontinuation of Manufacturing and Distribution; Product Recalls; and the FDA Consent Decree" in the Form 10-K;
  • the two agreements between the Company and the Office of Inspector General of the U.S. Department of Health and Human Services ("HHS OIG") pertaining to the exclusion of our former chief executive officer from participation in federal healthcare programs and pertaining to the dissolution of our ETHEX subsidiary, in order to resolve the risk of potential exclusion of our company, as more fully described in Note 15—"Commitments and Contingencies—Litigation and Governmental Inquiries" of the Notes to the Consolidated Financial Statements included in the Form 10-K;
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  • SOURCE K-V Pharmaceutical Company
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