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ViroPharma Provides Update on Vancocin(R)
Date:1/8/2008

EXTON, Pa., Jan. 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today provided the following update on its petition to the U.S. Food and Drug Administration (FDA) regarding Vancocin(R) (vancomycin hydrochloride capsules).

As part of the company's continuing efforts to assure the safety of patients afflicted with Clostridium difficile infection, ViroPharma yesterday presented its views on the in vitro dissolution bioequivalence method proposed by OGD, as well as important related health and safety information, to officials in the FDA's Office of Pharmaceutical Sciences (OPS), Office of Generic Drugs (OGD) and FDA legal counsel. ViroPharma appreciates the FDA's time and attention to this matter.

Consistent with the eventual availability of the slides presented by ViroPharma at the meeting in the FDA Docket for ViroPharma's petition on this matter, ViroPharma has posted these slides to its corporate website (http://www.viropharma.com/OGDpetition/).

Additionally, the company notes that the FDA's website docket at times experiences a delay in making Citizens Petition and supplement submissions available for public review through the internet. In the interest of transparency, ViroPharma also has posted to its website the following supplement submissions previously filed by ViroPharma, but which are not yet available on the FDA's website:
-- December 2007 Docket submission by ViroPharma detailing how ViroPharma

believes the OGD's actions regarding Vancocin are illustrative of

larger systemic problems at the OGD, and amending the company's

petition to request that the FDA take appropriate additional cor
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SOURCE ViroPharma Incorporated
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