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ViroPharma Announces Approval of Modernized Labeling for Vancocin® (vancomycin hydrochloride, USP) Capsules
Date:12/14/2011

oducts.aspx">http://www.viropharma.com/Products.aspx; the prescribing information for other countries can be found at www.viropharma.com

ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.

ViroPharma Forward Looking Statements

Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events, including our belief that Vancocin meets the requirements for, and thus received, three years of exclusivity and that the protected labeling cannot be omitted by a generic manufacturer prior to the expiration of the three year exclusivity period. There can be no assurance that: the FDA will confirm our belief that Vancocin meets the requirements for, and thus has received, three years of exclusivity, through listing an exclusivity code in the Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book), that even if FDA agrees that the label changes contained in our approved sNDA warrant exclusivity that the FDA would agree that omission of the protected labeling would render generic versions of Vancocin less safe and effective, the FDA will agree with the positions stated in ViroPharma's Vancocin-related submissions or that ViroPharma's efforts to oppose the FDA's bioequivalence recommendation for Vancocin through in vitro dissolution testing will be successful or that the courts reviewing the pending Vancocin related litigation will agree with our positions. In the event that the FDA does not grant three years of exclusivity i
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SOURCE ViroPharma Incorporated
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