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K-V Pharmaceutical Announces Divestiture of Generics Business to Zydus
Date:6/17/2011

roducts sold by the Company and its subsidiaries, including Makena™, and including competitive or responsive pricing changes;

(4) the possibility of not obtaining U.S. Food and Drug Administration ("FDA") approvals or delay in obtaining FDA approvals;

(5) new product development and launch, including the possibility that any product launch may be delayed or unsuccessful, including with respect to Makena™;

(6) 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™;

(7) the possibility that any period of exclusivity may not be realized, including with respect to Makena™, a designated Orphan Drug;

(8) 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;

(9) 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 Part I, Item—1 "Business—(b)Significant Developments—Discontinuation of Manufacturing and Distribution; Product Recalls; and the FDA Consent Decre
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SOURCE K-V Pharmaceutical Company
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