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ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
Date:3/18/2009

- Company Calls for Additional Scientific Data and Withdrawal of Guidance -

EXTON, Pa., March 18 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced its submission to the U.S. Food and Drug Administration (FDA) of comments on FDA's Office of Generic Drugs' (OGD) December 2008 draft guidance to establish the bioequivalence (BE) of generic copies of Vancocin(R) (vancomycin hydrochloride capsules).

Vancocin is the only approved product to treat Clostridium difficile-associated pseudomembranous colitis. This infection is one of the most common hospital acquired infections with up to 500,000 cases reported annually in health care facilities across the United States. Clostridium difficile infection (CDI) can be severe, and without proper treatment, the associated complications of the disease can be deadly. Vancocin is also approved to treat enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains

In March 2006, without notice to the public, OGD changed its bioequivalence standard from testing in humans to an in vitro dissolution test because it concluded that Vancocin was a "rapidly dissolving" drug product. In December 2008, OGD published data directly contradicting that conclusion, and at the same time released new draft guidance for establishing bioequivalence to Vancocin. OGD's new method nonetheless retains in vitro dissolution testing as the means to determine bioequivalence, provided that the generic product has the same inactive ingredients (Q1) and is present in the same amounts (Q2) as Vancocin. For generic versions of Vancocin that are not Ql and Q2 the same as Vancocin, FDA is recommending in vivo BE studies with clinical endpoints in patients with CDI.

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SOURCE ViroPharma Incorporated
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