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ViroPharma Announces Support by Advisory Committee of The Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride
Date:8/4/2009

EXTON, Pa., Aug. 4 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Pharmaceutical Science and Clinical Pharmacology Advisory Committee supports the FDA's Office of Generic Drugs (OGD) draft guidelines on bioequivalence (BE) for Vancocin(R) (vancomycin hydrochloride) capsules. Vancocin is used to treat severe, often life-threatening bacterial infections of the gastrointestinal (GI) tract, Clostridium difficile infection (CDI) and enterocolitis caused by Staphylococcus aureus. The draft guidelines, if approved, would allow generic manufacturers to use less rigorous standards, including in vitro rather than in vivo testing, for establishing BE rather than using comparative clinical trials. ViroPharma scientists and other leading experts voiced their concern that these new guidelines could jeopardize patient safety.

"We're appreciative that the FDA convened this advisory committee to provide a forum for open debate and discussion regarding a serious public health issue," said Vincent J. Milano, ViroPharma's president and chief executive officer. "While we're disappointed with the vote, we hope that the OGD will take every precaution to ensure that CDI patients will be treated with truly bioequivalent versions of vancomycin, given the life-threatening nature of the disease."

The Advisory Committee was asked if the proposed OGD guidelines and the use of in vitro dissolution methods are sufficient for establishing bioequivalence for generic vancomycin oral capsules. The Advisory Committee voted unanimously in favor of the proposed OGD recommendation to demonstrate bioequivalence through equivalent dissolution in media of pH 1.2, 4.5 and 6.8 for potential vancomycin HCl capsule
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SOURCE ViroPharma Incorporated
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