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K-V Pharmaceutical Comments on ACOG and SMFM Information Update Regarding Hydroxyprogesterone Caproate - FDA-Approved Makena™ and Compounded 17P
Date:10/13/2011

ing the possibility that any product launch may be delayed or unsuccessful, including with respect to Makena™;
  • acceptance of and demand for the Company's new pharmaceutical products, including 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 and acceptance of the degree of patient access to, and pricing for, Makena™;
  • 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 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 FDA and the Company's suspension of the production and shipment of all of the products that it manufactures (other than the Potassium Chloride Extended Release 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—2 "Management's Discussion and Analysis of Financial Condition and Results of Operations—Discontinuation of Manufacturing and Distribution; Product Recalls; and the FDA Consent Decree" in this Report;
  • 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 subsidi
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